Biomarker Analysis for Cervical Cancer Diagnosis

Recruiting at 167 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

877 Participants Needed

Trial Summary

What is the purpose of this trial?

This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.

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.

Is the Cytology Specimen Collection Procedure safe for humans?

The Cytology Specimen Collection Procedure, which involves collecting cervical cell samples for analysis, is generally considered safe. It is widely used in cervical cancer screening programs and has been implemented in various biobanks, ensuring high-quality sample handling and storage. ^{1 2 3 4 5}

How does this treatment differ from other treatments for cervical cancer?

This treatment is unique because it focuses on using multiple biomarkers to improve the accuracy of cervical cancer diagnosis, potentially enhancing the sensitivity and specificity of current screening methods like the Pap smear and HPV testing. Unlike traditional methods, this approach aims to identify specific molecular changes associated with cancer development, offering a more precise diagnostic tool. ^{6 7 8 9 10}

Research Team

Shu-Yuan liao

Principal Investigator

Gynecologic Oncology Group

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A complex intervention for workflow enhancement at the Swedish cervical cytology biobank. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of stationary colposcope and the Gynocular, by the Swede score systematic colposcopic system in VIA positive women: a crossover randomized trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Swedish cervical cytology biobank: sample handling and storage process. [2016]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of liquid-based gynecologic cytology on an HIV-positive population. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Improved endocervical sampling and HPV viral load detection by Cervex-Brush Combi. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Multiple biomarkers in molecular oncology. I. Molecular diagnostics applications in cervical cancer detection. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Biomarkers in cervical cancer screening. [2022]

8. Egypt pubmed.ncbi.nlm.nih.gov

Role of protein biomarkers in the detection of high-grade disease in cervical cancer screening programs. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Proteomic identification of differentially-expressed proteins in squamous cervical cancer. [2022]

10. United States 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. [2022]