Long Term Effects On Recipients of Hematopoietic Stem Cell Transplantation

Longitudinal Evaluation of Recipients of Hematopoietic Stem Cell Transplantation (HSCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Blood and Marrow Transplant (BMT)

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Nivedita A Kunte; Phone Number: 650-497-2038; Email: nkunte@stanford.edu
      • Principal Investigator: Ami Shah
      • Contact: Cancer Clinical Trials Office; Phone Number: (650) 498-7061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stanford Blood and Marrow Transplant clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Ami Shah, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 1995
• Primary Completion (Estimated): January 1, 2099
• Study Completion (Estimated): January 1, 2099

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimated): June 27, 2012

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-4134; 4134 (Other Identifier: Stanford IRB); 96823; PEDSBMT179 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No