Prospective Ascertainment for Late Effects Among Cancer Survivors
This study is currently recruiting participants.
Verified March 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01667952
First received: August 15, 2012
Last updated: March 14, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 15, 2012 | ||||||||
| Last Updated Date | March 14, 2013 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01667952 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Ascertainment for Late Effects Among Cancer Survivors | ||||||||
| Official Title ICMJE | Prospective Ascertainment for Late Effects Among Cancer Survivors | ||||||||
| Brief Summary | The purpose of this study is to establish a registry of cancer survivors. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Prospective |
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| 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. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients from the Adult Long-Term Follow-Up Program or Lymphoma Service will be recruited at a routine visit to MSKCC. |
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| Condition ICMJE | Pediatric or Young Adult Cancer Survivors | ||||||||
| Intervention ICMJE | Genetic: Family History Questionnaire (FHQ) and Saliva or blood samples
Consented subjects will be given the Family History Questionnaire (FHQ) (Appendix A), to complete either in clinic or at home. Saliva or blood samples will be collected in the clinic at the time of a routine visit. The patient will decide which type of sample they would like to donate. |
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| Study Group/Cohort (s) | Cancer Survivors
The purpose of this study is to establish a registry of cancer survivors. 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 cancer survivors.
Intervention: Genetic: Family History Questionnaire (FHQ) and Saliva or blood samples |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | August 2016 | ||||||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01667952 | ||||||||
| Other Study ID Numbers ICMJE | 12-143 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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