Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation
NCT ID: NCT02664389
Last Updated: 2020-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
289 participants
INTERVENTIONAL
2016-02-01
2017-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Genetic analysis of patient with early-onset breast cancer
Sequencing of 200 selected genes in patient with early-onset breast cancer without genomic alterations of BRCA1, BRCA2 or TP53
Genetic analysis
Sequencing of 200 selected genes in the different study populations
Genetic analysis of patient with early-onset ovarian cancer
Sequencing of 200 selected genes in patient with early-onset ovarian cancer without genomic alterations of BRCA1, BRCA2
Genetic analysis
Sequencing of 200 selected genes in the different study populations
Genetic analysis of patient with pediatric cancer
Sequencing of 200 selected genes in patient with pediatric cancer without genomic alteration of TP53
Genetic analysis
Sequencing of 200 selected genes in the different study populations
Genetic analysis of patient with early-onset colorectal cancer
Sequencing of 200 selected genes in patient with early-onset colorectal cancer without genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation or without genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
Genetic analysis
Sequencing of 200 selected genes in the different study populations
Genetic analysis of patient with multiple primary tumors
Sequencing of 200 selected genes in patient with Multiple primary malignant tumors without syndromic presentation
Genetic analysis
Sequencing of 200 selected genes in the different study populations
Interventions
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Genetic analysis
Sequencing of 200 selected genes in the different study populations
Eligibility Criteria
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Inclusion Criteria
For patient with early-onset breast cancer :
* Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2 or TP53
For patient with early-onset ovarian cancer :
* Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2
Patient with early-onset colorectal cancer :
* Invasive colorectal cancer diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
* No genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation
Patient with pediatric cancer :
* Non haematological tumour diagnosed before 16 years, with Li-Fraumeni presentation.
* No genomic alteration of TP53
Patient with Multiple primary malignant tumours :
* Multiple synchronous or metachronous primary malignant tumors with early-onset
* No syndromic presentation
Exclusion Criteria
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Thierry FREBOURG, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2015/160/HP
Identifier Type: -
Identifier Source: org_study_id
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