Biomarker Analysis for Cervical Cancer

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

409 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar 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.

Is the biospecimen collection process for cervical cancer research safe for humans?

The biobanking processes for cervical cancer research, including sample handling and storage, have been developed with quality control measures to ensure safety and reliability. These processes have been validated in different settings, such as in Sweden and Denmark, indicating that the biospecimen collection is generally safe for use in research. ^{1 2 3 4 5}

How is the Biospecimen Collection treatment for cervical cancer different from other treatments?

Biospecimen Collection is unique because it involves collecting biological samples from patients to better understand cervical cancer and develop personalized treatment strategies, rather than directly treating the cancer itself. This approach helps researchers identify biomarkers (biological indicators) that can guide the development of new therapies and improve patient outcomes. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Biospecimen Collection for cervical cancer?

The research highlights the importance of collecting biospecimens (samples of biological material) to establish biobanks, which are crucial for developing and testing new treatments for cervical cancer. These biobanks help researchers understand how different therapies work on cervical cancer, potentially leading to more effective treatments. ^{2 5 8 9 10}

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.

Patients must sign an approved informed consent document

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

Exclusion Criteria

I am not a male.

Patients unwilling or unable to provide informed consent for the study

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. England 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Establishment of a cervical cancer bio-bank for the Chinese population: from project-based sample collection to routine management. [2022]

3. 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]

4. Australia pubmed.ncbi.nlm.nih.gov

Decreased cytokeratin 7 expression correlates with the progression of cervical squamous cell carcinoma and poor patient outcomes. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comprehensive Identification of the Human Secretome as Potential Indicators in Treatment Outcome of HPV-Positive and -Negative Cervical Cancer Patients. [2021]

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

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

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

Quality Control of Biospecimens in a Danish Clinical Cytology Biobank. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

A critical analysis of cancer biobank practices in relation to biospecimen quality. [2020]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

Comparative proteomic profiling in squamous cell carcinoma of the uterine cervix. [2015]