Predictive Assays for Cervical Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Distant metastases, Prior cytotoxic therapy

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cervical cancer treatments by studying tumor responses to radiation therapy. It examines various methods to measure tumor characteristics, such as oxygen levels and pressure, which can influence treatment effectiveness. Participants will provide blood samples and undergo tumor biopsies to help researchers determine the best way to assess these tumor features. Candidates may qualify for this study if they have cervical cancer, are receiving radiation treatment, and have not undergone other anti-cancer therapies for this condition before joining. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future cervical cancer treatments.

Will I have to stop taking my current medications?

The trial protocol 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 these techniques are safe for assessing cervical cancer?

Research shows that both blood tests and tumor biopsies are generally safe and well-tolerated. Blood tests, routine in many medical exams, might cause some discomfort but are considered safe. Tumor biopsies involve taking a small tissue sample from the cervix to check for cancer. These common procedures might cause some discomfort or minor bleeding, but serious problems are rare.

Overall, medical settings widely use these procedures without major safety issues. Prospective trial participants should remember that these standard tests help in understanding cervical cancer and its treatment. It is important to discuss any concerns about these procedures with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve the way we predict and diagnose cervical cancer. Unlike traditional methods that rely heavily on imaging and physical exams, this trial is exploring the use of blood samples and tumor biopsies to develop predictive assays. These assays could help identify cervical cancer earlier and more accurately, potentially leading to better outcomes. By focusing on biological markers present in blood and tissue, this approach offers a promising new way to assess the risk and presence of cervical cancer, which could revolutionize current diagnostic practices.

What evidence suggests that these techniques are effective for assessing cervical cancer?

This trial will use blood samples and tumor biopsies to conduct assays on cervical cancer tissue. Research has shown that understanding the tumor's environment, including its oxygen levels and pressure, can improve treatment outcomes for cervical cancer. Tumors with low oxygen, known as hypoxia, often respond poorly to radiation therapy. Studies have found that measuring these factors can predict a patient's response to treatment. By using these methods, doctors aim to find the best way to assess these conditions, potentially tailoring treatments more effectively for each patient.

Who Is on the Research Team?

Anthony Fyles, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Michael Milosevic, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of cervical cancer, who are set to undergo radiation therapy as per the PMH Gynecology Group's treatment guidelines. It's open to those with clinical stage IB-IV and visible cervical disease but no distant metastases. Participants must not have received prior cytotoxic anti-cancer therapy for their condition and must provide signed informed consent.

Inclusion Criteria

My treatment plan includes radiation therapy as decided by my medical team.

I have not received chemotherapy for cervical cancer before joining this study.

My cancer has not spread to distant parts of my body.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radiation therapy and assessment of hypoxia and interstitial fluid pressures

6-8 weeks

Follow-up

Participants are monitored for tumour control and survival outcomes after radiation therapy

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Sampling
• Tumour Biopsies

Trial Overview The study is examining various techniques to measure hypoxia (low oxygen levels) and fluid pressures in cervix tumors, aiming to link these factors with tumor control and survival rates post-radiation therapy. The goal is to identify the best method for assessing these aspects of the tumor environment, which could help select patients for future trials targeting the microenvironment.

How Is the Trial Designed?

Group I: Assays on cervical cancer tissue Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

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. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601985/

4., Preventive and Adverse Effects of Cervical Cancer Screening This section considers the benefits of cervical screening, the accuracy of methods used for cervical screening and management, and the types of studies and data ...

2. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2025/09/11/new-study-reveals-a-hidden-risk-after-cervical-cancer

New study reveals a hidden risk after cervical cancer Hollings researchers uncovered data showing that women who survive cervical cancer are at greater risk of anal cancer years down the road.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834245

Clinical Validation of a Vaginal Cervical Cancer Screening ... This study found that the SC device is a safe and accurate method for primary HPV cervical cancer screening, offering a preferred alternative to in-clinic ...

4. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/hpv-testing-for-cervical-cancer-may-be-safe-at-longer-intervals-than-what-current-guidelines-recommend/

HPV Testing for Cervical Cancer May Be Safe at Longer ... HPV testing eight years after a negative result instead of the recommended five was found comparable to standard cytology screening.

5. cancer.org cancer.org/cancer/types/cervical-cancer/causes-risks-prevention/risk-factors.html

Risk Factors for Cervical Cancer Some studies have seen a higher risk of cervical cancer in women whose blood tests and cervical mucus showed evidence of past or current ...