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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01667952
Enrollment
1068
Registered
2012-08-17
Start date
2012-08-31
Completion date
2025-03-06
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric or Young Adult Cancer Survivors

Keywords

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

Brief summary

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

Interventions

GENETICFamily 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.

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.

OTHERBlood 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
establish a registry of DNA4 yearsFor 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026