- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01198743
Presence of Circulating Tumor DNA in Colorectal Cancer (ALGECOLS)
Search for the Presence of Genetic Alteration in the Plasma of Patients With Stage II-III Colorectal Cancers: Prognosis Impact
Cancer is a DNA disease characterized by the presence of genetics alterations in cancer cells.
The recent studies underline that these recurring alterations must be considered as a good molecular marker. In fact, they could use for tumor DNA detection in different biological fluids.
So, the main purpose is to define the presence of circulating tumor DNA in the patients plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and MIRCOSATELLIE instability).
These molecular analysis will be done both in tumor and plasma samples,
This trial allows to characterize the prognostic value of circulating tumoral DNA presence in colorectal cancer.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Two major issues appear in improving the prognosis of cancer patients, the first is early detection and the second is the risk of recurrence or the early diagnosis of recurrence in order to propose the most appropriate treatment for patients.
Cancer is a DNA disease that is characterized by the acquisition by the tumor cell during carcinogenesis of a number of recurrent genetic alterations. The development of molecular tools that can easily characterize these abnormalities specific to tumor cells, allows us to consider their use in clinical practice. These genetic alterations could represent useful molecular markers for detecting the presence of tumor DNA in various biological fluids including plasma of cancer patients. This circulating tumor DNA, whose nature is confirmed by the similarity of genetic alterations with those observed from DNA extracted from tumor cells of the patients, represents a molecular marker of cancer available from a single sample and could be an alternative to the use of more conventional markers such as CEA. We propose in this study to confirm the predictive value on the risk of recurrence or metastasis of circulating tumor DNA in plasma of patients with colorectal cancer from a cohort study (250 patients with non-metastatic colorectal cancer (Stage II and III). This is a multicenter prospective study. The cohort of patients will be followed for a minimum period of 36 months. A biological analysis of the tumor in search for the main genetic alterations of colorectal cancer cells will be made (KRAS, NRAS, TP53, BRAF and APC mutations as well as the presence of a microsatellite instability). These same genetic alterations will be sought on a plasma sample taken before surgery and during follow-up (9 samples in total). The objectives of this study will be 1/to assess the prognostic value of the presence of circulating tumor DNA in plasma, by searching for an association between the risk of and the presence of genetic alteration in the plasma of these patients, 2/to search for a relationship between initial rate of circulating tumor DNA and the risk of local recurrence,3/ to characterize the relationship between the type of alterations in the plasma at the initial diagnosis of circulating tumor DNA and the risk of recurrence 4/ to assess during the follow-up the prognostic value of the occurrence of tumor circulating DNA.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Paris, France, 75015
- HEGP
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- patients aged Superior to 18 and inferior to 85
- Colon or rectal cancer stage II and III should be surgically treated
- informed consent signed
Exclusion Criteria:
- patients suffered from synchronous metastasis disease in initial cancer diagnosis
- patients with 2 synchronous colorectal cancers
- receiving chemotherapy or radiotherapy, before operation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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local recidivism or metastasis reappearance
Délai: 6 months after operation
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6 months after operation
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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specificity and global safety
Délai: 36 monhs after operation
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36 monhs after operation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre LAURENT-PUIG, HEGP/ Paris Descartes University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P040433
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Essais cliniques sur Tumeurs colorectales
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City of Hope Medical CenterRecrutementTumeurs colorectales | Cancer colorectal | Troubles colorectaux | Adénocarcinome colorectal | Cancer colorectal stade II | Cancer colorectal stade III | Cancer colorectal stade IV | Polype colorectal | Tumeurs colorectales malignes | Polype adénomateux colorectal | Cancer colorectal stade I | Adénome colorectal... et d'autres conditionsÉtats-Unis, Italie, Chine, Espagne, Japon
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University of California, San FranciscoComplétéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Docbot, Inc.RecrutementAdénome colorectal | Adénocarcinome colorectal | Polype colorectal | ASS colorectalÉtats-Unis
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University of Southern CaliforniaNational Cancer Institute (NCI)RésiliéCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Actif, ne recrute pasCancer colorectal métastatique | Adénocarcinome colorectal | Cancer colorectal de stade IV | Cancer colorectal de stade IVA | Cancer colorectal de stade IVB | Carcinome colorectal réfractaire | Carcinome colorectal stable microsatellite métastatique | Cancer colorectal de stade IVCÉtats-Unis
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M.D. Anderson Cancer CenterRecrutementAdénocarcinome colorectal | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de... et d'autres conditionsÉtats-Unis
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Actif, ne recrute pasCancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RésiliéCancer rectal | Cancer du colon | Survivant du cancer | Adénocarcinome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal... et d'autres conditionsÉtats-Unis
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Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActif, ne recrute pasAdénome colorectal | Cancer colorectal de stade III AJCC v8 | Cancer colorectal de stade IIIA AJCC v8 | Cancer colorectal de stade IIIB AJCC v8 | Cancer colorectal de stade IIIC AJCC v8 | Cancer colorectal de stade 0 AJCC v8 | Cancer colorectal de stade I AJCC v8 | Cancer colorectal de stade II... et d'autres conditionsÉtats-Unis
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Roswell Park Cancer InstituteMerck Sharp & Dohme LLCRetiréAdénocarcinome colorectal métastatique | Adénocarcinome colorectal réfractaire | Microsatellite Stable | Cancer colorectal de stade IV AJCC v8 | Cancer colorectal de stade IVA AJCC v8 | Cancer colorectal de stade IVB AJCC v8 | Cancer colorectal de stade IVC AJCC v8 | Cancer colorectal de stade... et d'autres conditionsÉtats-Unis