Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

Cervical Cancer Clinical Trial

— BIO-RAIDs  

Official title:

Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428842
• Other study ID #: IC 2013-02 BIO-RAIDs
• Status: Completed
• Phase: N/A
• Start date: October 24, 2013
• Est. completion date: October 20, 2020

Study information

• Verified date: January 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: October 20, 2020
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Tumor biopsies
Tumor biopsies will be performed before and after treatment.
• Blood sampling
Blood sampling will be performed before and after treatment.

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest - Paul Papin	Angers
France	Institut Bergonié	Bordeaux
France	Centre Hospitalier Intercommunal de Créteil - CHI Créteil	Créteil
France	Centre Georges Francois Leclerc	Dijon
France	Centre Léon Bérard	Lyon
France	Institut Régional du Cancer de Montpellier - Val D'Aurelle	Montpellier
France	Institut de Cancérologie de Lorraine - ICL	Nancy
France	Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU	Nantes
France	Centre Antoine Lacassagne	Nice
France	Groupe Hospitalier Bichat	Paris	Ile De France
France	Hopital Europeen Georges Pompidou	Paris
France	Hôpital Tenon	Paris
France	Insitut Curie	Paris
France	Institut René Huguenin	Saint-Cloud
France	Centre Paul Strauss	Strasbourg
France	Institut de Cancérologie de Lorraine- ICL NANCY	Vandœuvre-lès-Nancy
France	Institut de Cancerologie Gustave Roussy	Villejuif
Germany	Mhh Hanover - Hanover Medical School	Hannover
Netherlands	Amsterdam Medical Center (AMC)	Amsterdam	Meibergdreef
Netherlands	Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL)	Amsterdam
Romania	Teo Health S.A. - Spitalul Sf. Constantin	Brasov
Romania	Spitalul Clinic Municipal "Gavril Curteanu"	Oradea
Romania	Clinica de radioterapie	Timisoara
Serbia	Clinic for operative oncology, Institute of oncology of Vojvodina	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between tumor biological profile and treatment response.	Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.	up to 6 months
Secondary	Progression Free Survival evaluation	Number of patient with no local/metastasis relapse 18 months after end of primary treatment course.	up to 18 months
Secondary	Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)	Description of primary treatment course regarding : Initial FIGO ( International Federation of Gynecology and Obstetrics; ) staging at baseline; Geographic location(country)	up to six months
Secondary	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)	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	up to 6 months
Secondary	Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)	Description of molecular tumor alterations regarding geographic location (country)	up to 24 months