Study Summary
This trial is testing a new, lower-dose treatment for HPV+ oropharynx cancer. They want to see if it's effective and if there are any side effects. They also want to find out which patients would benefit most from this treatment.
- HPV Positive Oropharynx Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 5 years
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Reduced Dose Radiation
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: PTV56 · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 12 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Näsman, Anders, Per Attner, Lalle Hammarstedt, Juan Du, Mathilda Eriksson, Geraldine Giraud, Sofie Ährlund-Richter, et al.. 2009. “Incidence of Human Papillomavirus (HPV) Positive Tonsillar Carcinoma in Stockholm, Sweden: An Epidemic of Viral-induced Carcinoma?”. International Journal of Cancer. Wiley. doi:10.1002/ijc.24339.
- Psyrri, Amanda, Rosa Anna DeFilippis, Anne P. B. Edwards, Kristin E. Yates, Laertes Manuelidis, and Daniel DiMaio. 2004. “Role of the Retinoblastoma Pathway in Senescence Triggered by Repression of the Human Papillomavirus E7 Protein in Cervical Carcinoma Cells”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-03-3739.
- Posner, M.R., J.H. Lorch, O. Goloubeva, M. Tan, L.M. Schumaker, N.J. Sarlis, R.I. Haddad, and K.J. Cullen. 2011. “Survival and Human Papillomavirus in Oropharynx Cancer in TAX 324: A Subset Analysis from an International Phase III Trial”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdr006.
- Harris, Stephen L., Leigh B. Thorne, William T. Seaman, D. Neil Hayes, Marion E. Couch, and Randall J. Kimple. 2010. “Association of P16ink4a Overexpression with Improved Outcomes in Young Patients with Squamous Cell Cancers of the Oral Tongue”. Head & Neck. Wiley. doi:10.1002/hed.21650.
- Riemer, Angelika B., Derin B. Keskin, Guanglan Zhang, Maris Handley, Karen S. Anderson, Vladimir Brusic, Bruce Reinhold, and Ellis L. Reinherz. 2010. “A Conserved E7-derived Cytotoxic T Lymphocyte Epitope Expressed on Human Papillomavirus 16-transformed HLA-A2+ Epithelial Cancers”. Journal of Biological Chemistry. Elsevier BV. doi:10.1074/jbc.m110.126722.
- Misiukiewicz, K., V. Gupta, B.A. Miles, R. Bakst, E. Genden, I. Selkridge, J.T. Surgeon, et al.. 2019. “Standard of Care Vs Reduced-dose Chemoradiation After Induction Chemotherapy in HPV+ Oropharyngeal Carcinoma Patients: The Quarterback Trial”. Oral Oncology. Elsevier BV. doi:10.1016/j.oraloncology.2019.06.021.
- Chaturvedi, Anil K., Eric A. Engels, William F. Anderson, and Maura L. Gillison. 2008. “Incidence Trends for Human Papillomavirus–related and –unrelated Oral Squamous Cell Carcinomas in the United States”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.14.1713.
- Münger, Karl, Amy Baldwin, Kirsten M. Edwards, Hiroyuki Hayakawa, Christine L. Nguyen, Michael Owens, Miranda Grace, and KyungWon Huh. 2004. “Mechanisms of Human Papillomavirus-induced Oncogenesis”. Journal of Virology. American Society for Microbiology. doi:10.1128/jvi.78.21.11451-11460.2004.
- Chaturvedi, Anil K., Eric A. Engels, Ruth M. Pfeiffer, Brenda Y. Hernandez, Weihong Xiao, Esther Kim, Bo Jiang, et al.. 2011. “Human Papillomavirus and Rising Oropharyngeal Cancer Incidence in the United States”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2011.36.4596.
- Rischin, Danny, Richard J. Young, Richard Fisher, Stephen B. Fox, Quynh-Thu Le, Lester J. Peters, Ben Solomon, et al.. 2010. “Prognostic Significance of P16ink4a and Human Papillomavirus in Patients with Oropharyngeal Cancer Treated on TROG 02.02 Phase III Trial”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2010.29.2904.
- Lorch, Jochen H, Olga Goloubeva, Robert I Haddad, Kevin Cullen, Nicholas Sarlis, Roy Tishler, Ming Tan, John Fasciano, Daniel E Sammartino, and Marshall R Posner. 2011. “Induction Chemotherapy with Cisplatin and Fluorouracil Alone or in Combination with Docetaxel in Locally Advanced Squamous-cell Cancer of the Head and Neck: Long-term Results of the TAX 324 Randomised Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(10)70279-5.
- Gillison, M. L.. 2000. “Evidence for a Causal Association Between Human Papillomavirus and a Subset of Head and Neck Cancers”. Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/92.9.709.
- Lassen, Pernille, Jesper G. Eriksen, Stephen Hamilton-Dutoit, Trine Tramm, Jan Alsner, and Jens Overgaard. 2009. “Effect of Hpv-associated P16ink4a Expression on Response to Radiotherapy and Survival in Squamous Cell Carcinoma of the Head and Neck”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2008.20.2853.
- Worden, Francis P., Bhavna Kumar, Julia S. Lee, Gregory T. Wolf, Kitrina G. Cordell, Jeremy M.G. Taylor, Susan G. Urba, et al.. 2008. “Chemoselection as a Strategy for Organ Preservation in Advanced Oropharynx Cancer: Response and Survival Positively Associated with HPV16 Copy Number”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.12.7597.
- Agoston, Elin S., Stephen J. Robinson, Karishma K. Mehra, Chandler Birch, Dana Semmel, Jelena Mirkovic, Robert I. Haddad, et al.. 2010. “Polymerase Chain Reaction Detection of HPV in Squamous Carcinoma of the Oropharynx”. American Journal of Clinical Pathology. Oxford University Press (OUP). doi:10.1309/ajcp1aawxe5jjclz.
- Porceddu, Sandro V., David I. Pryor, Elizabeth Burmeister, Bryan H. Burmeister, Michael G. Poulsen, Matthew C. Foote, Benedict Panizza, Scott Coman, David McFarlane, and William Coman. 2011. “Results of a Prospective Study of Positron Emission Tomography-directed Management of Residual Nodal Abnormalities in Node-positive Head and Neck Cancer After Definitive Radiotherapy with or Without Systemic Therapy”. Head & Neck. Wiley. doi:10.1002/hed.21655.
- Ang, K. Kian, Jonathan Harris, Richard Wheeler, Randal Weber, David I. Rosenthal, Phuc Felix Nguyen-Tân, William H. Westra, et al.. 2010. “Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0912217.
- Fakhry, C., W. H. Westra, S. Li, A. Cmelak, J. A. Ridge, H. Pinto, A. Forastiere, and M. L. Gillison. 2008. “Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial”. JNCI Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djn011.
- Best, Simon R., Patrick K. Ha, Ray G. Blanco, John R. Saunders Jr., Eva S. Zinreich, Marshall A. Levine, Sara I. Pai, et al.. 2011. “Factors Associated with Pharyngoesophageal Stricture in Patients Treated with Concurrent Chemotherapy and Radiation Therapy for Oropharyngeal Squamous Cell Carcinoma”. Head & Neck. Wiley. doi:10.1002/hed.21657.
- Bonner, James A, Paul M Harari, Jordi Giralt, Roger B Cohen, Christopher U Jones, Ranjan K Sur, David Raben, et al.. 2010. “Radiotherapy Plus Cetuximab for Locoregionally Advanced Head and Neck Cancer: 5-year Survival Data from a Phase 3 Randomised Trial, and Relation Between Cetuximab-induced Rash and Survival”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(09)70311-0.
- Anderson, K S, J Wong, G D'Souza, A B Riemer, J Lorch, R Haddad, S I Pai, et al.. 2011. “Serum Antibodies to the HPV16 Proteome as Biomarkers for Head and Neck Cancer”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/bjc.2011.171.
- Machtay, Mitchell, Jennifer Moughan, Andrew Trotti, Adam S. Garden, Randal S. Weber, Jay S. Cooper, Arlene Forastiere, and K. Kian Ang. 2008. “Factors Associated with Severe Late Toxicity After Concurrent Chemoradiation for Locally Advanced Head and Neck Cancer: An RTOG Analysis”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.14.8841.
- Tachezy, Ruth, Jan Klozar, Linda Rubenstein, Elaine Smith, Martina Saláková, Jana Šmahelová, Viera Ludvíková, Eliška Rotnáglová, Roman Kodet, and Eva Hamšíková. 2009. “Demographic and Risk Factors in Patients with Head and Neck Tumors”. Journal of Medical Virology. Wiley. doi:10.1002/jmv.21470.
- Hafkamp, Harriët C, Jeroen J Mooren, Sandra MH Claessen, Boris Klingenberg, Adri C Voogd, Fredrik J Bot, J Peter Klussmann, et al.. 2009. “P21cip1/waf1 Expression Is Strongly Associated with Hpv-positive Tonsillar Carcinoma and a Favorable Prognosis”. Modern Pathology. Springer Science and Business Media LLC. doi:10.1038/modpathol.2009.23.
- Adelstein, David J., Yi Li, George L. Adams, Henry Wagner Jr, Julie A. Kish, John F. Ensley, David E. Schuller, and Arlene A. Forastiere. 2003. “An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients with Unresectable Squamous Cell Head and Neck Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2003.01.008.
- Taylor, S G, 4th, A K Murthy, J M Vannetzel, P Colin, M Dray, D D Caldarelli, S Shott, E Vokes, J L Showel, and J C Hutchinson. 1994. “Randomized Comparison of Neoadjuvant Cisplatin and Fluorouracil Infusion Followed by Radiation Versus Concomitant Treatment in Advanced Head and Neck Cancer.”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.1994.12.2.385.
- Kumar, Bhavna, Kitrina G. Cordell, Julia S. Lee, Francis P. Worden, Mark E. Prince, Huong H. Tran, Gregory T. Wolf, et al.. 2008. “EGFR, P16, HPV Titer, Bcl-xl and P53, Sex, and Smoking as Indicators of Response to Therapy and Survival in Oropharyngeal Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.12.7662.
- Weinberger, Paul M., Ziwei Yu, Bruce G. Haffty, Diane Kowalski, Malini Harigopal, Janet Brandsma, Clarence Sasaki, et al.. 2006. “Molecular Classification Identifies a Subset of Human Papillomavirus–associated Oropharyngeal Cancers with Favorable Prognosis”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.00.3335.
- Gillison, Maura L.. 2006. “Human Papillomavirus and Prognosis of Oropharyngeal Squamous Cell Carcinoma: Implications for Clinical Research in Head and Neck Cancers”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2006.07.1829.
- Cmelak, Anthony J., Sigui Li, Meredith A. Goldwasser, Barbara Murphy, Michael Cannon, Harlan Pinto, David I. Rosenthal, Maura Gillison, and Arlene A. Forastiere. 2007. “Phase II Trial of Chemoradiation for Organ Preservation in Resectable Stage III or IV Squamous Cell Carcinomas of the Larynx or Oropharynx: Results of Eastern Cooperative Oncology Group Study E2399”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.10.8951.
- Schache, Andrew G., Triantafilos Liloglou, Janet M. Risk, Anastasia Filia, Terence M. Jones, Jon Sheard, Julia A. Woolgar, et al.. 2011. “Evaluation of Human Papilloma Virus Diagnostic Testing in Oropharyngeal Squamous Cell Carcinoma: Sensitivity, Specificity, and Prognostic Discrimination”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-11-0388.
- Licitra, Lisa, Federica Perrone, Paolo Bossi, Simona Suardi, Luigi Mariani, Raffaella Artusi, Maria Oggionni, et al.. 2006. “High-risk Human Papillomavirus Affects Prognosis in Patients with Surgically Treated Oropharyngeal Squamous Cell Carcinoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2005.04.6136.
- Staar, Susanne, Volker Rudat, Hartmut Stuetzer, Andreas Dietz, Peter Volling, Michael Schroeder, Michael Flentje, Hans Edmund Eckel, and Rolf-Peter Mueller. 2001. “Intensified Hyperfractionated Accelerated Radiotherapy Limits the Additional Benefit of Simultaneous Chemotherapy—results of a Multicentric Randomized German Trial in Advanced Head-and-neck Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/s0360-3016(01)01544-9.
- Maxwell, Jessica H., Bhavna Kumar, Felix Y. Feng, Francis P. Worden, Julia S. Lee, Avraham Eisbruch, Gregory T. Wolf, et al.. 2010. “Tobacco Use in Human Papillomavirus–positive Advanced Oropharynx Cancer Patients Related to Increased Risk of Distant Metastases and Tumor Recurrence”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-09-2350.
- Adelstein, David J., Yi Li, George L. Adams, Henry Wagner Jr, Julie A. Kish, John F. Ensley, David E. Schuller, and Arlene A. Forastiere. 2003. “An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients with Unresectable Squamous Cell Head and Neck Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2003.01.008.
- Bonner, James A, Paul M Harari, Jordi Giralt, Roger B Cohen, Christopher U Jones, Ranjan K Sur, David Raben, et al.. 2010. “Radiotherapy Plus Cetuximab for Locoregionally Advanced Head and Neck Cancer: 5-year Survival Data from a Phase 3 Randomised Trial, and Relation Between Cetuximab-induced Rash and Survival”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(09)70311-0.
- Forastiere A, Maor M, Weber R, Pajak, T, Glisson B, Trotti A, Ridge J, et al. Long term results of Intergroup RTOG 91-11: A Phase III trial to preserve the larynx - Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. Proceedings of the American Society of Clinical Oncology. 2006:5517.
- Ang, K. Kian, Jonathan Harris, Richard Wheeler, Randal Weber, David I. Rosenthal, Phuc Felix Nguyen-Tân, William H. Westra, et al.. 2010. “Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0912217.
- Cmelak, Anthony J., Sigui Li, Meredith A. Goldwasser, Barbara Murphy, Michael Cannon, Harlan Pinto, David I. Rosenthal, Maura Gillison, and Arlene A. Forastiere. 2007. “Phase II Trial of Chemoradiation for Organ Preservation in Resectable Stage III or IV Squamous Cell Carcinomas of the Larynx or Oropharynx: Results of Eastern Cooperative Oncology Group Study E2399”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.10.8951.
- Fakhry, C., W. H. Westra, S. Li, A. Cmelak, J. A. Ridge, H. Pinto, A. Forastiere, and M. L. Gillison. 2008. “Improved Survival of Patients with Human Papillomavirus-positive Head and Neck Squamous Cell Carcinoma in a Prospective Clinical Trial”. JNCI Journal of the National Cancer Institute. Oxford University Press (OUP). doi:10.1093/jnci/djn011.
- Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
- Staar S, Rudat V, Stuetzer H, Dietz A, Volling P, Schroeder M, Flentje M, Eckel HE, Mueller RP. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1161-71. doi: 10.1016/s0360-3016(01)01544-9. Erratum In: Int J Radiat Oncol Biol Phys 2001 Oct 1;51(2):569.
- Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.
- Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.
- Psyrri A, DeFilippis RA, Edwards AP, Yates KE, Manuelidis L, DiMaio D. Role of the retinoblastoma pathway in senescence triggered by repression of the human papillomavirus E7 protein in cervical carcinoma cells. Cancer Res. 2004 May 1;64(9):3079-86. doi: 10.1158/0008-5472.can-03-3739.
- Ringstrom E, Peters E, Hasegawa M, Posner M, Liu M, Kelsey KT. Human papillomavirus type 16 and squamous cell carcinoma of the head and neck. Clin Cancer Res. 2002 Oct;8(10):3187-92.
- Gillison ML. Human papillomavirus and prognosis of oropharyngeal squamous cell carcinoma: implications for clinical research in head and neck cancers. J Clin Oncol. 2006 Dec 20;24(36):5623-5. doi: 10.1200/JCO.2006.07.1829. No abstract available.
- Nasman A, Attner P, Hammarstedt L, Du J, Eriksson M, Giraud G, Ahrlund-Richter S, Marklund L, Romanitan M, Lindquist D, Ramqvist T, Lindholm J, Sparen P, Ye W, Dahlstrand H, Munck-Wikland E, Dalianis T. Incidence of human papillomavirus (HPV) positive tonsillar carcinoma in Stockholm, Sweden: an epidemic of viral-induced carcinoma? Int J Cancer. 2009 Jul 15;125(2):362-6. doi: 10.1002/ijc.24339.
- Munger K, Baldwin A, Edwards KM, Hayakawa H, Nguyen CL, Owens M, Grace M, Huh K. Mechanisms of human papillomavirus-induced oncogenesis. J Virol. 2004 Nov;78(21):11451-60. doi: 10.1128/JVI.78.21.11451-11460.2004. No abstract available.
- Gillison ML, Koch WM, Capone RB, Spafford M, Westra WH, Wu L, Zahurak ML, Daniel RW, Viglione M, Symer DE, Shah KV, Sidransky D. Evidence for a causal association between human papillomavirus and a subset of head and neck cancers. J Natl Cancer Inst. 2000 May 3;92(9):709-20. doi: 10.1093/jnci/92.9.709.
- Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008.
- Taylor SG 4th, Murthy AK, Vannetzel JM, Colin P, Dray M, Caldarelli DD, Shott S, Vokes E, Showel JL, Hutchinson JC, et al. Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol. 1994 Feb;12(2):385-95. doi: 10.1200/JCO.1994.12.2.385.
- Weinberger PM, Yu Z, Haffty BG, Kowalski D, Harigopal M, Brandsma J, Sasaki C, Joe J, Camp RL, Rimm DL, Psyrri A. Molecular classification identifies a subset of human papillomavirus--associated oropharyngeal cancers with favorable prognosis. J Clin Oncol. 2006 Feb 10;24(5):736-47. doi: 10.1200/JCO.2004.00.3335. Epub 2006 Jan 9.
- Licitra L, Perrone F, Bossi P, Suardi S, Mariani L, Artusi R, Oggionni M, Rossini C, Cantu G, Squadrelli M, Quattrone P, Locati LD, Bergamini C, Olmi P, Pierotti MA, Pilotti S. High-risk human papillomavirus affects prognosis in patients with surgically treated oropharyngeal squamous cell carcinoma. J Clin Oncol. 2006 Dec 20;24(36):5630-6. doi: 10.1200/JCO.2005.04.6136.
- Marshall Posner, MD 2016. "Quarterback 2b - Sequential Therapy With Reduced Dose Chemoradiotherapy for HPV Oropharynx Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02945631.
Frequently Asked Questions
Is it possible for interested participants to join this research endeavor?
"As evidenced by the clinicaltrials.gov site, this medical trial is still open for enrollment. Initially posted on April 25th 2016 and most recently revised August 23rd 2022, it seeks to recruit new participants." - Anonymous Online Contributor
What is the accepted patient capacity for this clinical examination?
"Affirmative. Clinicaltrials.gov data reveals that recruitment for this clinical trial was launched on April 25th 2016 and the details were most recently amended on August 23rd 2022. 50 participants are being sought at a single site." - Anonymous Online Contributor