Cervical Cancer Clinical Trial
— MOLLYOfficial title:
Identification of a MOLecuLar Signature Predicting Radiosensitivity in Locally Advanced Cervical Cancer Patients (LACC) Treated With Exclusive radiochemotherapY: a Pilot Study
NCT number | NCT06016868 |
Other study ID # | 5773 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2023 |
Est. completion date | August 1, 2025 |
The importance of radioresistance in cervical cancer treatment failure indicates that certain biomarkers may be useful for cervical cancer treatment individualization. However, to date, no study has analyzed the role of the gene expression signature of the three RNA species (ANXA2-NDRG1-STAT1) to predict radiosensitivity/resistance in cervical cancer patients undergoing exclusive CTRT. The previously validated three-gene signature may enable stratification in LACC patients treated with the current standard of care, represented by exclusive CTRT.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Universitario Agostino Gemelli, IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To test the performance of the molecular signature. | To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients. | 60 months |
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