Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-01-31

Study Completion Date

2099-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood and Marrow Transplant (BMT)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ami Shah

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Nivedita A Kunte

Role: primary

Cancer Clinical Trials Office

Role: backup

Other Identifiers

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IRB-4134

Identifier Type: -

Identifier Source: org_study_id