Clinical trial

Genetic Investigation of Cancer Predisposition

Name
HSC20200666H
Description
Clinical information and samples (blood, saliva, and tumor) will be collected from patients with multiple cancers and/or a family history of cancer as well as from affected and unaffected relatives; samples will be systematically sequenced and evaluated for candidate driver mutations.
Trial arms
Trial start
2024-10-01
Estimated PCD
2030-06-01
Trial end
2035-12-01
Status
Not yet recruiting
Treatment
DNA or RNA Sequencing
Samples will be used for whole exome (DNA) or RNA sequencing
Size
100
Primary endpoint
Identification of Rare Genetic Variant
through study completion- approximately 6-12 months
Identification of somatic (tumor only) mutation
through study completion- approximately 6-12 months
Identification of Rare Genetic Variant in family members
through study completion- approximately 6-12 months
Eligibility criteria
Inclusion Criteria: 1. Any age 2. Meets at least ONE of the following: 1. Personal history (with documented diagnosis) of cancer before the age of 50 2. Personal history of more than one primary cancer 3. Documented diagnosis of cancer AND family history of that same cancer type or multiple other cancers that do not fit classical criteria of hereditary cancer syndromes 4. Documented diagnosis of a rare cancer AND family history of rare cancers that do not fit classical criteria of hereditary cancer syndromes 5. There is the same type of cancer in several generations of a family 6. Documented diagnosis of multicentric cancers (e.g bilateral cancers in paired organs, or multifocal cancers in single organs) that usually occur as single lesions when presented sporadically 7. Early onset cancer (before the age of 50, or breast cancer before age 45) AND family history of early onset cancer Capable of providing access to detailed medical records and family history of cancer Exclusion Criteria: 1. Established genetic diagnosis of a known hereditary cancer syndrome that is compatible with the clinical presentation 2. Incarcerated
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '60 Months', 'designInfo': {'observationalModel': 'FAMILY_BASED', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-01-08

1 organization

1 product

2 indications

Indication
Cancer