Validation of a genetic signature for predicting treatment response in cervical cancer
Prospective Study for the Validation of the Genetic Signature 354849 to Predict the Response to Standard Treatment in Patients With Locally Advanced Cervical Cancer
This study is testing if a specific set of 27 genes can help predict how well women with advanced cervical cancer will respond to a combination of chemotherapy and brachytherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 189 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Institute of Cancerología Government |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Mexico, Mexico City and 1 other locations) |
| Trial ID | NCT04067882 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to validate a genetic signature consisting of 27 genes as a predictor of treatment response in patients with locally advanced cervical cancer. The study will involve 189 women diagnosed with cervical cancer at clinical stages IB2-IVA, who have not received prior treatment. Tumor samples will be collected and analyzed using quantitative PCR to assess gene expression levels, which will then be used to calculate a prognostic score indicating the likelihood of a positive response to concomitant chemotherapy followed by brachytherapy.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with locally advanced cervical cancer (IB2-IVA) who have not received any prior treatment.
Not a fit: Patients with previous treatments for cervical cancer or those with distant metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting treatment responses in cervical cancer, potentially leading to more personalized and effective treatment strategies.
How similar studies have performed: While there have been studies on genetic signatures in cervical cancer, this specific approach to standardizing a prognostic method remains novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women over 18 years old * Cervical Cancer at IB2-IVA FIGO´s clinical stages * Histology: squamous, adenosquamous or adenocarcinoma * No previous treatment * No distance metastases, discard by PET/CT * Functional State ECOG (Eastern Cooperative Oncology Group) 0-2 * Candidates to receive standard chemoradiotherapy treatment followed by brachytherapy Exclusion Criteria: * Previous chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies * Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum. * Previous systemic chemotherapy for the current cervical cancer.
Where this trial is running
Mexico, Mexico City and 1 other locations
- Instituto Nacional de Cancerologia — Mexico, Mexico City, Mexico (Recruiting)
- David Cantu de Leon — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: David F Cantú-deLeón, MD, PhD — National Cancer Institute of Mexico
- Study coordinator: David F Cantú-de León, MD, MSc. PhD
- Email: dfcantu@gmail.com
- Phone: +5215537093156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.