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

This study is currently recruiting participants.

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Contacts and Locations

Verified September 2017 by Memorial Sloan Kettering Cancer Center

Sponsor:

ClinicalTrials.gov Identifier:

NCT01667952

First Posted: August 17, 2012

Last Update Posted: September 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

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

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

Primary Outcome Measures:

establish a registry of DNA [ Time Frame: 4 years ]
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 2018
Estimated Primary Completion Date:	August 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	August 15, 2012
First Posted:	August 17, 2012
Last Update Posted:	September 6, 2017
Last Verified:	September 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:


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

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