Cervical Cancer
Conditions
Keywords
Cervical cancer, Tumor biopsies, Standard treatment, Molecular profile, Next Generation Sequencing
Brief summary
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
Interventions
PROCEDURETumor biopsies
Tumor biopsies will be performed before and after treatment.
PROCEDUREBlood sampling
Blood sampling will be performed before and after treatment.
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between tumor biological profile and treatment response. | up to 6 months | Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival evaluation | up to 18 months | Number of patient with no local/metastasis relapse 18 months after end of primary treatment course. |
| Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country) | up to six months | Description of primary treatment course regarding : * Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline * Geographic location(country) |
| Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects) | up to 6 months | Description of standard treatment's side effects will be assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale |
| Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country) | up to 24 months | Description of molecular tumor alterations regarding geographic location (country) |
Countries
France, Germany, Netherlands, Romania, Serbia
Outcome results
None listed