Long-term follow-up for patients who had a stem cell transplant
Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation
This study is checking in on people who had a stem cell transplant to see how they are doing long-term and to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03000244 on ClinicalTrials.gov |
What this trial studies
This observational study aims to provide long-term follow-up care for individuals who have undergone allogeneic hematopoietic stem cell transplantation (HCT) and their related stem cell donors. Participants will have annual visits that include physical exams, medical history assessments, and screening tests to monitor for late complications associated with HCT. The study seeks to collect clinical data, blood, and tissue samples to better understand the long-term effects of HCT and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have survived at least one year after undergoing HCT, as well as their related stem cell donors.
Not a fit: Patients with active disease relapse or new hematologic malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of late complications after HCT and improve long-term care for survivors.
How similar studies have performed: Other studies have shown success in understanding long-term outcomes in HCT survivors, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA FOR PATIENT SUBJECTS: * Patients who underwent HCT for any indication (malignant or non-malignant) and are surviving one year or more from the date of HCT (patients may be at any time point after HCT as long as it is \>=1 year). * Age \>= 4 years * Ability of patient or patient's Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document * Patients will need to have a primary physician within the US (primary care, oncologist, hematologist, etc.) that will provide continued comprehensive care throughout the patient's participation in the study EXCLUSION CRITERIA FOR PATIENT SUBJECTS: -Patients with active disease relapse or new hematologic malignancy including post-transplant lymphoproliferative disorder (PTLD) are excluded from protocol enrollment. INCLUSION CRITERIA FOR DONOR SUBJECTS: * Related stem cell donors of patients meeting the above criteria as a donor of stem cells or leukocytes * Age \>= 4 years * Ability of patient or patient's Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document INCLUSION CRITERIA FOR PARENTS COMPLETING SURVEYS: * Parents/guardians of minors enrolled on the study who have undergone HCT * Willingness to complete surveys about the minor that underwent HCT
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Najla El Jurdi, M.D. — National Cancer Institute (NCI)
- Study coordinator: Ashley E Carpenter
- Email: carpentera@mail.nih.gov
- Phone: (240) 550-0492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.