Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers
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Purpose
The purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. Blood specimens will be frozen and stored for analysis at a later date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to perform this study, patients and members of their families will be asked to provide blood samples and/or saliva samples. Individuals will be asked to provide a history of cancer in their relatives at the time the blood sample is given. No relatives will be contacted before they have been asked by a family member if they wish to participate in this study.
| Condition | Phase |
|---|---|
|
Breast Neoplasms Ovarian Neoplasms Colonic Neoplasms Prostatic Neoplasms Uterine Cervical Neoplasms Leukemia Lymphoma, Non-Hodgkin |
Phase 1 Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers |
- To establish a bank of DNA and frozen lymphoblastoid cell lines for the purpose of facilitating genetic epidemiology investigations of familial cancers. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- A related goal is to provide patients with cancer and their living relatives the opportunity to preserve DNA samples so that they may be used for future genetic counseling regarding inherited cancer risk. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood, Saliva, Tumor Tissue, Normal Tissue
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 1994 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Patients can provide either a blood or saliva sample for the protocol. For blood samples, two tubes of blood (approximately 20 cc) will be drawn from the patient, utilizing a sterile technique. The tubes will be rocked so as to mix the blood with the additive (EDTA) in the tubes. For saliva samples, approximately 2-4 ml of saliva will be collected in specialized Oragene DNA Self-Collection Kit tubes.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Primary care clinic
Inclusion Criteria:
- Patients accepted for referral to the Cancer Family Clinic of the Department of Medicine at Memorial Sloan-Kettering Cancer Center are eligible for participation in this study. Such patients should have a history of cancers of the breast, ovary, colon, prostate, uterus, non-Hodgkin's lymphoma, leukemia, soft tissue sarcoma, endocrine neoplasms, or other malignancies presenting in first degree relatives or in successive generations as part of a suspected cancer family syndrome.
- Family members of probands including parents, sisters, brothers, half-brothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible.
- This study involves research which presents no greater than minimal risk to children. The assent of any minor should be obtained before the patient is entered into this study.
Contacts and Locations| Contact: Kenneth Offit, MD | 646-888-4050 |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Kenneth Offit, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00579163 History of Changes |
| Other Study ID Numbers: | 93-102 |
| Study First Received: | December 19, 2007 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Blood Salvia Tissue |
Additional relevant MeSH terms:
|
Colonic Neoplasms Breast Neoplasms Neoplasms Uterine Cervical Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Ovarian Neoplasms Prostatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
ClinicalTrials.gov processed this record on May 19, 2013