Biomarker Analysis for Cervical Cancer

No longer recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Male, Perianal dysplasia, Oropharyngeal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the frequency of anal cancer in women with certain types of cancer or pre-cancer conditions in the cervix, vagina, or vulva. By collecting samples during regular pelvic exams, researchers hope to learn more about the human papillomavirus (HPV) and its connection to these cancers. Women diagnosed with specific cervical, vaginal, or vulvar conditions, such as high-grade dysplasia (abnormal cell growth found in routine pap tests), may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could lead to better understanding and prevention of anal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this biospecimen collection is safe?

Research has shown that collecting samples such as anal, cervical, vaginal, and oral samples is generally safe and well-received by patients. Studies indicate that over 80% of participants responded positively to collecting their own samples, suggesting that most find it acceptable and manageable. Some participants might test positive for high-risk HPV, necessitating further follow-up. Overall, no major safety concerns have been reported with the sample collection process itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on analyzing biomarkers for cervical cancer through the collection of biospecimens. Unlike traditional diagnostic methods that primarily rely on imaging and biopsies, this approach involves collecting samples from multiple sites, including anal, cervical, vaginal, and oral areas during routine pelvic exams. This comprehensive sampling could potentially reveal new biomarkers that lead to earlier and more accurate detection of cervical cancer, offering a non-invasive and potentially more effective way to monitor the disease.

What evidence suggests that this biospecimen collection is effective for studying anal dysplasia and cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer?

This trial involves collecting samples to study the connection between certain cancers and the human papillomavirus (HPV). Although no treatment undergoes testing, research has shown that HPV is a major cause of cervical, vaginal, and vulvar cancers. By examining these samples, scientists aim to understand how often anal cancer might occur alongside these other cancers. This could help doctors better predict and manage cancer risks in the future. However, it's important to note that this study focuses on gathering information, not testing a new treatment.

Who Is on the Research Team?

Kathleen M. Schmeler

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women diagnosed with high-grade lesions or cancer of the cervix, vagina, or vulva. Participants can have any stage of squamous cell carcinoma, adenocarcinoma, or in-situ adenocarcinoma and must consent to the study. Men and those with prior anal dysplasia/cancer or HPV-related throat cancer are excluded.

Inclusion Criteria

I have been diagnosed with a high-grade lesion from a pap test.

I have a confirmed diagnosis of advanced cervical, vaginal, or vulvar cancer.

Patients must sign an approved informed consent document

Exclusion Criteria

Patients unwilling or unable to provide informed consent for the study

I am not a male.

I have had squamous cell cancer or pre-cancer in my anal area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biospecimen Collection

Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biospecimen collection

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection

Trial Overview The study is collecting tissue samples from patients to analyze biomarkers related to human papillomavirus (HPV). It aims to understand how often anal cancer occurs in patients who have cervical, vaginal, or vulvar cancers.

How Is the Trial Designed?

Group I: Screening (biospecimen collection) Experimental Treatment 2 Interventions

Patients undergo collection of anal, cervical, vaginal, and oral samples during their scheduled pelvic exam.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A large patient-derived xenograft (PDX) biobank for recurrent or metastatic cervical cancer was established with a 63.8% success rate, preserving the biological and genomic characteristics of the original tumors, which is crucial for developing effective treatments.

The PDX models successfully mirrored patient responses to chemotherapy and demonstrated that a combination of adoptive cell therapy and neratinib effectively inhibited tumor growth in cervical cancer patients with HER2 mutations, highlighting a potential new therapeutic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of a high-fidelity patient-derived xenograft model for cervical cancer enables the evaluation of patient's response to conventional and novel therapies. Liu, L., Wu, M., Huang, A., et al.[2023]

In a study of 1997 women aged 35-45 in China, those with moderate to high HPV loads had significantly higher cumulative incidence rates of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), indicating that HPV load is a strong predictor of cervical cancer risk.

The findings suggest that a moderate or high HPV load could serve as an effective triage indicator for HPV-positive women, potentially streamlining cervical cancer screening and management, as it showed similar efficacy to cytologic findings in identifying women at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Human Papillomavirus DNA Load in Predicting the Long-term Risk of Cervical Cancer: A 15-Year Prospective Cohort Study in China. Zhao, X., Zhao, S., Hu, S., et al.[2022]

The Swedish Cervical Cytology Biobank (SCCB) is a pioneering national initiative that collects and stores liquid-based gynecological cell samples from women in cervical cancer screening programs, with over 120,000 samples expected to be processed this year.

A standardized protocol for sample handling and storage has been developed through extensive literature review and collaboration, ensuring high-quality management and creating a valuable resource for cancer research linked to national registries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Swedish cervical cytology biobank: sample handling and storage process. Perskvist, N., Norman, I., Eklund, C., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144659/

Self-Collection for Cervical Cancer Screening in a Safety- ... Overall, 84 of 609 participants (13.8%) had a positive high-risk HPV test result that required follow-up (77 with cytology and 7 with colposcopy) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404364/

The acceptability, safety, and performance of primary ... The acceptability of self-collection is high with more than 80% of participants indicated positive responses to at least five (out of six) ...

3. aacrjournals.org aacrjournals.org/cebp/article/31/1_Supplement/PO-238/676269/Abstract-PO-238-Implementing-a-culturally

Abstract PO-238: Implementing a culturally-appropriate ... Background: Native American women experience twice the rate and mortality of cervical cancer compared to non-Hispanic white women.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06676150

Self-collection for HPV Testing to Improve Cervical Cancer ... This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11939108/

Self-Collected Vaginal Specimens for HPV Testing Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for primary HPV screening of asymptomatic average-risk ...