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Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01629017
Collaborator
(none)
800
Enrollment
1
Location
1248
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project allows for the systematic collection and analysis of long-term follow-up clinical parameters in children who have received a stem cell transplant. The data collected will assist in determining appropriate intervention and treatment plans for patients enrolled on this study. In addition, future patients may benefit by having the ability to anticipate problems and develop methods of prevention or early intervention.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary Objective: Implement long-term follow-up guidelines for children, adolescents and young adults who are survivors of HSCT while establishing a database which captures the survivor's lifetime care.

    Secondary Objectives:

    • Collect evidence-based data through a structured framework of periodic physical examination, laboratory and medical tests to monitor late effects in our HSCT survivors.

    • Establish standards of care for late effects of therapy post HSCT for malignant and non-malignant diagnoses.

    • Provide early identification and intervention towards recognized problems, as well as consistent education to foster a healthy lifestyle to all survivors.

    • Collect blood and tissue samples to study immune reconstitution of all immune cell types and learn more about immune reconstitution and its affect on post-HSCT complications and disease free survival.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Evaluation of Recipients of Hematopoietic Stem Cell Transplantation (HSCT)
    Study Start Date :
    Jan 1, 1995
    Anticipated Primary Completion Date :
    Jan 1, 2099
    Anticipated Study Completion Date :
    Jan 1, 2099

    Outcome Measures

    Primary Outcome Measures

    1. Collection of data and tissue samples with the goal of establishing a systematic follow-up care for HSCT recipients and a comprehensive database which can capture the particularities of survivors' clinical status through their life span. [This research study is expected to continue as long as we continue to perform clinical trials for children with diseases that involve the bone marrow or are affected by bone marrow production.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant is scheduled to receive OR has received a hematopoietic stem cell transplant (HSCT) for any condition.

    • Participant may have had a HSCT in another institution than Lucile Packard Children's Hospital (LPCH) yet has transferred follow-up long-term care to our institution and is being seen through the late-effects clinic from the Pediatric HSCT program.

    • Participant AND/OR parent/legally authorized representative is able to provide written informed consent and assent (as applicable) for participation.

    Exclusion Criteria:

    • Participant has relapsed from a malignant diagnosis post HSCT and is not being worked-up for a new HSCT.

    • Participant or patient's authorized guardian is unable to provide consent and assent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Ami Shah, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT01629017
    Other Study ID Numbers:
    • IRB-4134
    • 96823
    • 4134
    • PEDSBMT179
    First Posted:
    Jun 27, 2012
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 28, 2021