Etude : CASOHAR /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CASOHAR

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 19/02/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Transcriptome mammaire, ovarien et et leucocytaire de gènes de prédisposition héréditaire aux cancers du sein et/ou de l'ovaire

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study requires two steps:

- The first part of the study will be conducted on a population of 20 women free of breast cancer and, or ovarian Family (healthy volunteers controls) and without a known family history of breast and or ovarian cancer.

Mapping the level of blood (leukocytes) and the breast tissue will be drawn for the same individual on the physiological profiles splicing of the messenger RNA of genes involved in this predisposition, targeted by high-throughput sequencing of RNA (RNASeq).

A direct comparison of RNA splicing patterns between blood and breast tissue from the same witness will detect any differences between these two tissues.

-The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls with no known family history of breast and, or ovarian cancer.

Analysis of the results will highlight potential splicing abnormalities.

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : For Healthy Volunteers

Inclusion Criteria:

For population A

Women without a history of breast cancer and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer
Age 18-65 years
Women targeted for breast reduction surgery
Agreeing to participate in the study (collection of signed informed consent)

For population B

Women over the age of 18, with no previous history of breast and / or ovarian cancer and no family history of breast and / or early ovarian cancer in first and second degree relatives, ( diagnosis before age 50 for breast cancer and before age 60 for ovarian cancer).
Women to be operated on for a hysterectomy with annexectomy or an annexectomy in a benign indication

For population C :

Women with a history of breast cancer between 50 and 65 years of age but no history of ovarian cancer and no family history of breast and / or ovarian cancer in first- and second-degree relatives before 50 years of age breast cancer and before age 60 for ovarian cancer
Women who have been treated for breast cancer and undergoing contralateral symmetrization surgery

Critères de non-inclusion :
Men
Personal history (for population A and B) or family history (populations A, B, C) of breast and / or ovarian cancer (known breast or ovarian cancer in their family of 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer)
Population C: breast cancer under 50 years
Persons deprived of liberty or guardianship (including curatorship)
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02560818
Promoteur :
Centre François BACLESSE
Type de sponsor : Institutionnel
Centre François BACLESSE
14000 CAEN

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Raffaèle FAUVET

TEC / ARC / IDE :
Vincent LEON
leon-v@chu-caen.fr

Statut de l'essai : OUVERT

MAJ : 19/02/2020