Clinical trial · Interventional
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
NCT02428842CI-TRIAL-00063352BIO-RAIDscompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
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 sampling | Procedure | — | UNRESOLVED |
| Tumor biopsies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Tumor biopsies and blood sampling
- description
- Patient will undergo standard care with tumor and blood sampling before and after treatment. Blood and tumor sampling will also be performed at disease progression/relapse.
- interventionNames
- Procedure: Tumor biopsies
- Procedure: Blood sampling
Primary outcomes (1)
- measure
- Correlation between tumor biological profile and treatment response.
- timeFrame
- up to 6 months
- description
- Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
Secondary outcomes (4)
- measure
- Progression Free Survival evaluation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. No prior treatment for cervical cancer. 2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type). 3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage 4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more). 5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment). 6. Age ≥ 18 years. 7. ECOG (Eastern Cooperative Oncology Group) 0-2. 8. Life expectancy \> 6 months. 9. Patient eligible for standard treatment (according to standards of each center). 10. Patient having health care insurance. 11. Informed and signed consent by patient. (DICOM = Digital Imaging and Communications in Medicine) Exclusion Criteria: 1. Patient enrolled in a clinical trial involving an investigative new agent. 2. Co morbidity, preventing patient to tolerate the proposed standard treatment. 3. Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix). 4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 . 5. Patient deprived from ability to decide on her own. 6. Patient unable to have a regular follow up for geographical, social or psychological reasons. 7. Pregnancy or patient old enough to procreate and not using effective contraceptive method.
References
Publications (2)
- DERIVEDChouchane-Mlik O, Oniga A, Latouche A, Halladjian M, Kleine-Borgmann FB, Gerardy JJ, Mittelbronn M, Kamal M, Scholl SM. Systematic assessment of tumor necrosis at baseline in cervical cancer - An independent factor associated with poor outcome. Hum Pathol. 2024 Jan;143:62-70. doi: 10.1016/j.humpath.2023.12.003. Epub 2023 Dec 20. PMID 38135059
- DERIVEDNgo C, Samuels S, Bagrintseva K, Slocker A, Hupe P, Kenter G, Popovic M, Samet N, Tresca P, von der Leyen H, Deutsch E, Rouzier R, Belin L, Kamal M, Scholl S; RAIDs consortium http://www.raids-fp7.eu/. From prospective biobanking to precision medicine: BIO-RAIDs - an EU study protocol in cervical cancer. BMC Cancer. 2015 Nov 4;15:842. doi: 10.1186/s12885-015-1801-0. PMID 26531748