Long Term Effects On Recipients of Hematopoietic Stem Cel... | NCT01629017

Studies
Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

NCT01629017

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Dec 24, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Blood and Marrow Transplant (BMT)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1995

Primary Completion Date

Jan 2099Estimated

Completion Date

Jan 2099Estimated

First Submitted Date

Jun 25, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Stanford Blood and Marrow Transplant clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ami Shah	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine	Recruiting	Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided