Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579163
First received: December 19, 2007
Last updated: July 31, 2014
Last verified: July 2014
  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. If they do wish to participate, the relatives should indicate this by returning the "Family Member Consent for Contact Form" After we receive this form, arrangements may be made for the family member to send in a blood and/or saliva sample or to come in person to provide the sample to us.

Except for family history, no medical information provided by one member of a family will be discussed with other family members. At the end of this form, we will also ask for your permission to be contacted in the future to discuss information about your health, additional research with your samples and/or certain research findings possibly related to your sample.


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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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. The sample(s) may also be used to detect new genes or changes in genes that may tell us who is at risk for certain types of cancer and/or other diseases.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579163

Contacts
Contact: Kenneth Offit, MD 646-888-4050

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
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: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Blood
Salvia
Tissue

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Ovarian Neoplasms
Lymphoma, Non-Hodgkin
Uterine Cervical Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014