Biomarker Analysis for Cervical Cancer Diagnosis

Not currently recruiting at 185 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: GOG Foundation

Disqualifiers: Hysterectomy, Endometrial cancer, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the diagnosis of cervical lesions in individuals with abnormal cervical cells. Researchers are studying biomarkers such as CA-IX, p16, and HPV to determine if they can better identify these lesions and aid in treatment planning. The trial includes a Cytology Specimen Collection Procedure to gather cervical cell samples for Laboratory Biomarker Analysis. It is suitable for those recently diagnosed with abnormal cervical cells or HPV and planning further cervical exams. As an unphased trial, this study allows participants to contribute to groundbreaking research that may enhance future diagnostic methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this biomarker analysis is safe for diagnosing cervical lesions?

Research shows that the methods used in this trial, such as collecting and studying biological markers from cervical cells, are generally safe. Studies have found that collecting cells from the cervix using liquid-based cytology, a common lab test, is well-tolerated by patients, with no significant risks or side effects reported.

The purpose of examining markers like CA-IX, p16, and HPV is to improve the diagnosis and treatment planning for cervical issues. These markers have been thoroughly studied and are safe to analyze. The focus is on learning more about cervical cancer, not on testing new drugs or performing invasive procedures.

Overall, the procedures in this study are standard and safe for participants, similar to tests already used in medical settings to diagnose cervical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to diagnose cervical cancer by analyzing specific biomarkers. Unlike traditional methods that rely heavily on Pap smears and HPV testing, this approach targets biomarkers like CA-IX, p16, Ki-67, and MCM2 using immunohistochemistry (IHC), alongside high-risk HPV DNA and genotyping. This method could potentially offer a more precise and early detection of cervical cancer, improving outcomes by identifying the disease at a stage when it’s most treatable.

What evidence suggests that this trial's procedures could be effective for diagnosing cervical lesions?

Research has shown that certain markers in the body, such as p16, Ki-67, and MCM2, can improve the accuracy of diagnosing cervical cell changes. In this trial, participants will provide liquid-based cytology specimens for marker analysis. Studies have found that women testing positive for both p16 and Ki-67 face a higher risk of developing cervical cancer. Testing for these markers can thus identify those needing earlier treatment. A review of multiple studies confirmed that using these markers is more accurate than traditional screening methods. Overall, these tests can enhance the early and effective detection of cervical cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Shu-Yuan liao

Principal Investigator

Gynecologic Oncology Group

Are You a Good Fit for This Trial?

This trial is for patients with abnormal cervical cells, diagnosed within the last 6 months, who have not had a hysterectomy or treatment for vaginal/cervical cancer. They must consent to personal health information release and be willing to undergo a full examination of the uterus and cervix if HPV positive.

Inclusion Criteria

Patients must have signed an approved informed consent and authorization permitting release of personal health information

I was diagnosed with abnormal glandular cells or AIS in the last 6 months and can wait for a specific test.

I have HPV and agree to a detailed exam of my uterus and cervix within 6 months after my AGC or AIS diagnosis.

Exclusion Criteria

Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed

I have had a hysterectomy.

I have had endometrial, vaginal, or cervical cancer or pre-cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection and Analysis

Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via immunohistochemistry and for the presence of high risk HPV DNA and HPV genotyping.

Baseline

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cytology Specimen Collection Procedure
• Laboratory Biomarker Analysis

Trial Overview The study is testing how well certain biomarkers like CA-IX, p16, proliferative markers, and HPV can diagnose cervical lesions. It involves collecting cervical cell samples (LBC specimen) and analyzing them in a lab.

How Is the Trial Designed?

Group I: Ancillary-Correlative (biomarkers in cervical cancer) Experimental Treatment 2 Interventions

Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via IHC and for the presence of high risk HPV DNA and HPV genotyping.

Who Is Running the Clinical Trial?

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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/PMC6962779/

The effect of p16/Ki-67 and p16/mcm2 on the detection ... We found that women with both p16/Ki-67-negative and p16/mcm2-negative had the lowest risk, while women with the two biomarkers both positive had the highest ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7960869/

Role of Cervical Cancer Biomarkers p16 and Ki67 in ... Study was conducted to know the efficacy of immunostaining with p16/Ki-67 in predicting the presence of significant lesion in cases of mild cytological atypia.

3. tcr.amegroups.org tcr.amegroups.org/article/view/100718/html

Immunocytochemical staining for p16, Ki-67, and MCM2 in the ... This study aimed to evaluate the diagnostic performance of p16, Ki-67, and minichromosome maintenance protein 2 (MCM2) as biomarkers in cervical cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S295019542500044X

Liquid biopsy biomarkers in cervical cancer: A systematic ... This meta-analysis confirmed that biomarkers showed high accuracy for cervical cancer diagnosis. Abstract. Background/Objectives. Liquid ...

5. waocp.com waocp.com/journal/index.php/apjcb/article/view/1046

Meta-analysis on the Diagnostic Performance of p16/Ki-67 ... The study suggested that dual immunostaining is a better approach for detecting HPV-induced cervical cancer compared to traditional screening methods.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9892968/

Circulating cervical cancer biomarkers potentially useful in ... There are several studies showing biomolecules, proteins, non-coding RNAs (ncRNAs), and circulating DNA (cDNA) with a great potential to be useful biomarkers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9509511/

Exploration of biomarkers for the diagnosis, treatment and ... This article is a general descriptive review summarizing various CC biomarkers discovered through high throughput omics technologies with most ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0168365925005668

Novel biomarker discovery-coupled plasma therapy with ... This study explores biomarker-driven non-thermal plasma (NTP) therapy as a localized therapeutic strategy with deep tissue penetration.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05462951

Clinical Trial of Molecular Biomarkers in Women With ... This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624031419

Biomarker Expression and Clinical Outcomes in ... BIOEMBRACE was designed to study the impact of biomarkers in addition to clinicopathological factors on disease outcomes in patients treated with ...