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Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor biopsies and blood sampling | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor biopsies | Procedure | Tumor biopsies will be performed before and after treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival evaluation | Number of patient with no local/metastasis relapse 18 months after end of primary treatment course. | up to 18 months |
| Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country) |
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Inclusion Criteria:
(DICOM = Digital Imaging and Communications in Medicine)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Paul Papin | Angers | 49933 | France | |||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38135059 | Derived | Chouchane-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. | |
| 26531748 |
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| Blood sampling | Procedure | Blood sampling will be performed before and after treatment. |
|
Description of primary treatment course regarding :
|
| up to six months |
| 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 |
| 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 |
| Bordeaux |
| France |
| Centre Hospitalier Intercommunal de Créteil - CHI Créteil | Créteil | 94010 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Centre Léon Bérard | Lyon | France |
| Institut Régional du Cancer de Montpellier - Val D'Aurelle | Montpellier | 34298 | France |
| Institut de Cancérologie de Lorraine - ICL | Nancy | France |
| Institut de Cancérologie de l'Ouest - RENE GAUDUCHEAU | Nantes | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Insitut Curie | Paris | 75248 | France |
| Hôpital Tenon | Paris | France |
| Institut René Huguenin | Saint-Cloud | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Institut de Cancérologie de Lorraine- ICL NANCY | Vandœuvre-lès-Nancy | 54519 | France |
| Institut de Cancerologie Gustave Roussy | Villejuif | 94805 | France |
| Groupe Hospitalier Bichat | Paris | Île-de-France Region | 75877 | France |
| Mhh Hanover - Hanover Medical School | Hanover | 30625 | Germany |
| Amsterdam Medical Center (AMC) | Amsterdam | Meibergdreef | 91105 AZ | Netherlands |
| Netherland Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL) | Amsterdam | 1006 BE | Netherlands |
| Teo Health S.A. - Spitalul Sf. Constantin | Brasov | 500091 | Romania |
| Spitalul Clinic Municipal "Gavril Curteanu" | Oradea | 410469 | Romania |
| Clinica de radioterapie | Timișoara | 300041 | Romania |
| Clinic for operative oncology, Institute of oncology of Vojvodina | Kamenitz | 21204 | Serbia |
| Ngo 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. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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