Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by Memorial Sloan Kettering Cancer Center

Sponsor:

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT01667952

First received: August 15, 2012

Last updated: July 14, 2016

Last verified: July 2016

History of Changes

Purpose

The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.

Condition	Intervention
Pediatric or Young Adult Cancer Survivors	Genetic: Family History Questionnaire (FHQ) Genetic: Salvia sample Other: Blood sample


Study Type:	Observational
Study Design:	Observational Model: Family-Based Time Perspective: Prospective
Official Title:	Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Salvia

U.S. FDA Resources

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

Primary Outcome Measures:

establish a registry of DNA [ Time Frame: 4 years ] [ Designated as safety issue: No ]
For the purpose of facilitating future genetic laboratory investigations of late effects among of survivors of cancer, tumors, or a related illness. Patients in the ALTFU Program are followed for secondary malignant neoplasms and other adverse outcomes (so-called "late effects") including cardiomyopathy, pulmonary fibrosis, cardiac valvular pathology, osteoporosis, and others. The following data will be ascertained from each study participant: (1) family history information will be ascertained using the Family History Questionnaire (Appendix A); and (2) saliva or blood samples for genetic analysis.

Biospecimen Retention: Samples With DNA

Saliva or blood samples will be collected in the clinic at the time of a routine visit.


Estimated Enrollment:	1000
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2017
Estimated Primary Completion Date:	August 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cancer Survivors The purpose of this study is to establish a registry of survivors of cancer, tumors,or a related illness. The registry will include detailed family history and germline DNA. Ultimately, we hope to improve our understanding of genetic susceptibility to secondary malignant neoplasms and other late effects among survivors of cancer, tumors, or a related illness.	Genetic: Family History Questionnaire (FHQ) Consented subjects will be given the Family History Questionnaire (FHQ) to complete either in clinic or at home. Subjects who chose to complete the FHQ at home will be given a stamped envelope with a label. For participants who are children and cannot fill out the questionnaire on their own, the clinic RSA will instruct the parent, guardian, or legally authorized representative (LAR) present to fill out the questionnaire, reminding them that the "You" in the questionnaire refers to their child. Genetic: Salvia sample The saliva samples will be collected in Oragene DNA Self-Collection Kits or a similar product. Patients will be instructed to donate about 2ml of saliva into a vial, which contains 2ml of product. Oragene or similar solution. Other: Blood sample Subjects will be offered the option of a blood collection instead of saliva. For adult subjects who opt for blood collection, two tubes of blood (approximately 20cc) will be drawn from the utilizing a sterile technique. For subjects under the age of 18 who opt for blood collection, approximately 3-5cc of blood will be collected utilizing a sterile technique.

Groups/Cohorts

Assigned Interventions

Cancer Survivors

The purpose of this study is to establish a registry of survivors of cancer, tumors,or a related illness. The registry will include detailed family history and germline DNA. Ultimately, we hope to improve our understanding of genetic susceptibility to secondary malignant neoplasms and other late effects among survivors of cancer, tumors, or a related illness.

Genetic: Family History Questionnaire (FHQ)

Consented subjects will be given the Family History Questionnaire (FHQ) to complete either in clinic or at home. Subjects who chose to complete the FHQ at home will be given a stamped envelope with a label. For participants who are children and cannot fill out the questionnaire on their own, the clinic RSA will instruct the parent, guardian, or legally authorized representative (LAR) present to fill out the questionnaire, reminding them that the "You" in the questionnaire refers to their child.

Genetic: Salvia sample

The saliva samples will be collected in Oragene DNA Self-Collection Kits or a similar product. Patients will be instructed to donate about 2ml of saliva into a vial, which contains 2ml of product. Oragene or similar solution.

Other: Blood sample

Subjects will be offered the option of a blood collection instead of saliva. For adult subjects who opt for blood collection, two tubes of blood (approximately 20cc) will be drawn from the utilizing a sterile technique. For subjects under the age of 18 who opt for blood collection, approximately 3-5cc of blood will be collected utilizing a sterile technique.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from the Adult Long-Term Follow-Up Program, the Pediatric Long Term Follow-up Program, or Lymphoma Service will be recruited at a routine visit to MSKCC.

Criteria

Inclusion Criteria:

English speaking
A personal history of cancer tumor, or a related illness
Followed in the the Adult Long Term Follow Up Program, Pediatric Long Term Follow Up Program, or Lymphoma Service at MSKCC

Exclusion Criteria:

Evidence of active progression of disease or recurrence
Neurocognitive deficits that impair ability to give informed consent.

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: NCT01667952

Contacts


Contact: Emily Tonorezos, MD, MPH	646-888-8080
Contact: Ken Offit, MD	646-888-4050

Locations


United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Emily Tonorezos, MD,MPH 646-888-8080
Contact: Kenneth Offit, MD 646-888-4050
Principal Investigator: Emily Tonorezos, MD, MPH

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators


Principal Investigator:	Emily Tonorezos, MD, MPH	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01667952 History of Changes
Other Study ID Numbers:	12-143
Study First Received:	August 15, 2012
Last Updated:	July 14, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:


Family History Questionnaire (FHQ) Blood sample Salvia sample 12-145

ClinicalTrials.gov processed this record on September 26, 2016

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