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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 4, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date August 15, 2012
First Posted Date August 17, 2012
Last Update Posted Date December 4, 2018
Study Start Date August 2012
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2013)
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.
Original Primary Outcome Measures
 (submitted: August 15, 2012)
establish a registry of DNA [ Time Frame: 4 years ]
For the purpose of facilitating future genetic laboratory investigations of late effects among cancer survivors. 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.
Change History Complete list of historical versions of study NCT01667952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Official Title Prospective Ascertainment for Late Effects Among Survivors of Cancer, Tumor, or a Related Illness
Brief Summary The purpose of this study is to establish a registry of survivors of cancer, tumor, or a related illness.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva or blood samples will be collected in the clinic at the time of a routine visit.
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.
Condition Pediatric or Young Adult Cancer Survivors
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Genetic: Family History Questionnaire (FHQ)
  • Genetic: Salvia sample
  • Other: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 19, 2017)
2000
Original Estimated Enrollment
 (submitted: August 15, 2012)
1000
Estimated Study Completion Date August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Emily Tonorezos, MD, MPH 646-888-8080
Contact: Ken Offit, MD 646-888-4050
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01667952
Other Study ID Numbers 12-143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Emily Tonorezos, MD, MPH Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2018