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

500 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment involving blood sampling and tumor biopsies for cervical cancer?

Research suggests that using blood samples to detect circulating tumor DNA (ctDNA) can help in the early diagnosis and monitoring of cervical cancer, making it a promising method for managing the disease. ^{1 2 3 4 5}

Is the predictive assay for cervical cancer safe for humans?

The research discusses various methods for cervical cancer screening and monitoring, such as liquid biopsy and circulating tumor DNA analysis, but it does not provide specific safety data for these methods. However, these techniques are generally considered safe as they involve blood sampling and analysis, which are common and low-risk procedures in medical practice. ^{1 3 6 7 8}

How does this treatment for cervical cancer differ from existing options?

This treatment is unique because it uses predictive assays to identify biomarkers that can help determine the long-term risk of cervical cancer in HPV-positive women, potentially offering a more personalized approach compared to standard screening methods like the Pap test or HPV-DNA test. ^{1 2 7 9 10}

What is the purpose of this trial?

The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.

Research Team

Anthony Fyles, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Michael Milosevic, MD

Principal Investigator

University Health Network, Princess Margaret Hospital

Eligibility Criteria

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.

I have been diagnosed with cervical cancer.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Detection of human papillomavirus mRNA and cervical cancer cells in peripheral blood of cervical cancer patients with metastasis. [2017]

2. 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]

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

How to evaluate emerging technologies in cervical cancer screening? [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficient mutation screening for cervical cancers from circulating tumor DNA in blood. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Surgical treatment of early stage cervical carcinoma at Leids University Medical Center, 1984-1996: depth of invasion, number and bilaterality of metastatic lymph nodes prognostic for recurrence]. [2006]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Liquid Biopsy in Cervical Cancer: Hopes and Pitfalls. [2021]

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

Dynamic analysis of circulating tumor DNA to predict prognosis and monitor therapeutic response in metastatic relapsed cervical cancer. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[Study of quantitative detection of circulating DNA in the plasma of patients with cervical lesion]. [2022]

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

Using plasma cell-free DNA to monitor the chemoradiotherapy course of cervical cancer. [2020]