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

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ClinicalTrials.gov Identifier: NCT01667952
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Study Start Date : August 2012
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: August 17, 2012    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Family History Questionnaire (FHQ)
Blood sample
Salvia sample
12-145