Identifying biomarkers in advanced cervical cancer patients
Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: a Pilot Study
This study is trying to see if certain gene markers in patients with advanced cervical cancer can help predict how well they'll respond to radiation and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome) |
| Trial ID | NCT06016868 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the gene expression signature of three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity and resistance in patients with locally advanced cervical cancer (LACC) undergoing exclusive chemoradiation therapy (CTRT). By examining tumor tissue and blood samples, the study seeks to stratify patients based on their predicted response to treatment, potentially leading to more personalized therapeutic approaches. The research builds on previous findings that identified a three-gene signature associated with radiosensitivity in cervical cancer. This study is crucial as it addresses a gap in the clinical application of biomarkers for treatment individualization in cervical cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically-confirmed locally advanced cervical cancer who have not received prior definitive treatment.
Not a fit: Patients with rare cervical cancer histologies or those who have undergone neo-adjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for cervical cancer patients, improving their outcomes.
How similar studies have performed: While previous studies have identified biomarkers for cervical cancer, this specific approach using the three-gene signature is novel and has not been extensively tested in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix * FIGO 2018 stage IIB and IIIC1\[38\] * Treatment with exclusive chemoradiation including brachytherapy * Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer * Has radiographically evaluable disease, measurable per RECIST 1.1 * Negative pregnancy test * Adequate hematologic, renal, and hepatic functions, with following blood tests: Neutrophils \> 1500/μL Platelets \> 100.000/ μL Hemoglobin \> 9 g/dL Serum creatinine \< 1.8 mg/dL Total bilirubin \< 3 mg/ dL LDH \< 3x normal value GOT \< 3x normal value GPT \< 3x normal value ALP \< 3 x normal value Exclusion Criteria: * Rare cervical cancer histologies (neuroendocrine, glassy cells, serous, endometrioid etc) * Neo-adjuvant treatment * Patients included in other clinical trials * Patients refusing to sign informed consent * Contraindications to radiotherapy * Contraindications to pelvic radiotherapy: ulcerative colitis, diverticulitis, chronic pelvic inflammatory disease, previous pelvic radiotherapy
Where this trial is running
Rome
- Policlinico Universitario Agostino Gemelli, IRCCS — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Gabriella Maria F Ferrandina, PhD
- Email: mariagabriella.ferrandina@policlinicogemelli.it
- Phone: 0630158667
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.