Biomarker evaluation in advanced stage cervical cancer by an international working group. Tumor Stages (1B1-4).

Recruiting

Conditions: Cervical cancer
cervical carcinoma
10038594

Registration Number: NL-OMON41533

Lead Sponsor: Institut Curie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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 0-2.
8)Life expectancy > 6 months.
9)Patient eligible for standard treatment
10) Patient having health care insurance.
11) Informed and signed consent by patient.

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Frequency of dominant genetic or protein alterations<br /><br>• Non response to primary treatment at 6 months as determined by:<br /><br>I Pathology<br /><br>II Cross sectional imaging by MRI (pelvic mass) and CT<br /><br>scan (extrapelvic).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Determination of PFS at 18 months in correlation with dominant genetic or<br /><br>protein alterations<br /><br>• Descriptive analysis of standard treatment modalities applied in<br /><br>participating European countries<br /><br>• Descriptive analysis of grade 3&4 treatment-associated side effects and<br /><br>toxicities<br /><br>• Descriptive analysis of molecular alterations frequency according to<br /><br>geographic location.</p><br>