Clinical trial · Observational
Identification of a MOLecuLar Signature in Locally 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Procedure | — | UNRESOLVED |
| Tumor tissue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Interventional
- interventionNames
- Procedure: Tumor tissue
- Procedure: Blood sample
Primary outcomes (1)
- measure
- To test the performance of the molecular signature.
- timeFrame
- 60 months
- description
- To test the performance of the molecular signature in predicting response to exclusive CTRT in LACC patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
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