Genomic Structural Variation in Cancer Susceptibility
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Purpose
This study will look for new types of gene changes that may be related to cancer in some patients. Some gene changes (mutations) are passed on from parents to offspring (child). Other gene changes are new and are seen for the first time in a child. They are not seen in the parent.
Some of these new gene changes may cause cancers in the offspring. We will look for these gene changes by studying both patients with cancer and their family members without cancer. In this study, we will be able to find gene changes that occur in the cancer patient but not in the rest of the family. Knowing the role that new gene changes play in cancer risk may help us find people at a higher risk of getting cancer.
| Condition |
|---|
|
Breast Cancer Colon Cancer Germ Cell Cancer Neuroblastoma Rectal Cancer Sarcoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based |
| Official Title: | Genomic Structural Variation in Cancer Susceptibility |
- To determine the frequency of de novo germline copy number variants (CNVs) in cancer affected probands using an ascertainment of "trios" consisting of cancer patients and their unaffected biologic parents [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To explore the role of germline homozygosity in cancer susceptibility by determining the frequency and length of autozygous regions in patients with cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood or saliva sample
| Estimated Enrollment: | 1250 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The majority of eligible probands will be identified prospectively through the clinics of the Clinical Genetics, Medical Oncology and Pediatric Oncology Services of MSKCC by the patient's physician, the protocol investigator, or a research team member.
Inclusion Criteria:
Proband with one of the following (both incident and prevalent cases will be collected):
- Colorectal cancer diagnosed at or under the age of 50.
- Breast cancer diagnosed at or under the age of 45.
- Germ cell tumor diagnosed at or under the age of 40.
- Pediatric neuroblastoma or primary bone sarcoma diagnosed at or under the age of 21.
- Cancer of any type diagnosed at or under the age of 40
- Proband must have living unaffected biologic mother and father available and eligible for participation in the study.
Unaffected parents:
- Must be the biologic mother and biologic father of affected proband.
- Must have (by self-report) no history of cancer other than non-melanomatous skin cancer or cervical cancer in situ.
Unaffected sibling(s):
- Must be age 18 or older and have same biologic parents as proband.
Exclusion Criteria:
- Known genetic mutation in proband or a family history that is indicative of hereditary cancer susceptibility.
Contacts and Locations| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Zsofia Stadler, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00996710 History of Changes |
| Other Study ID Numbers: | 09-068 |
| Study First Received: | October 15, 2009 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Genome-wide 09-068 |
Additional relevant MeSH terms:
|
Breast Neoplasms Colonic Neoplasms Rectal Neoplasms Disease Susceptibility Genetic Predisposition to Disease Neuroblastoma Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Disease Attributes Pathologic Processes Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013