Protocol For Collecting Data On Patients With Childhood Cancer

Progress in the development of curative therapy for pediatric malignancies has resulted in increasing numbers of long-term childhood cancer survivors. This protocol is a means to provide continuing review of outcome and late toxicity for all patients actively being treated and previously treated for childhood cancer at St. Jude Children's Research Hospital.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer
• Intervention / Treatment: Other: Data Collection

Detailed Description

Previously at St. Jude Children's Research Hospital, monitoring and reporting of late treatment sequelae developing in protocol participants have occurred at the discretion of individual investigators. A formal mechanism for coordinating long-term follow-up data collection of late cancer-related toxicity did not exist within the institution, nor did a central data repository to facilitate correlation of clinical and treatment factors predisposing to toxicity. Central coordination of late effects monitoring and reporting at St. Jude offers the potential benefit of facilitating timely communication about life-threatening or unanticipated late toxicity to investigators developing contemporary therapeutic studies and monitoring predisposed survivors who may benefit from preventive or corrective interventions.

This study centralizes the late effects monitoring and reporting of St. Jude therapeutic studies which have been completed under the auspices of one umbrella protocol. This protocol is not an independent research study, but rather a means to aggregate outcome and late effects reporting regarding all patients actively being treated and previously treated at St. Jude Children's Research Hospital for the diagnosis of childhood cancer. Data collected on the patient will include only those data obtained through clinical staff or Cancer Registry encounters that are documented in the medical record or provided by the patient or family on follow-up forms. All monitored patients will have information provided regarding status (alive/expired), relapse, subsequent malignancies, and death for any cause. Clinical outcomes, toxicity and late effects monitoring planned in the study on which the patient was originally enrolled will be collected by the principal investigators of that study. Subjects will then be followed in the After Completion of Therapy on an annual basis for 10 years from diagnosis (or 10 years from completion of salvage therapy for relapse) or until they are at least 18 years of age. They will undergo specific screening laboratory, diagnostic imaging studies, and subspecialty consultations as medically indicated by predisposing cancer treatment exposures. At the time of discharge from ACT clinic the subject will begin annual lifetime follow-up by the St. Jude Cancer Registry.

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Melissa M Hudson, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Melissa M Hudson, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Melissa M Hudson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients actively being treated and previously treated at St. Jude Children's Research Hospital for childhood cancer.

Description

Inclusion Criteria:

• All St Jude patients actively being followed or treated for childhood cancer

Exclusion Criteria:

• St. Jude consult only patients
• St. Jude patients permanently discharged from care and follow-up Permanently discharged patients include patients who have electively transferred their oncologic care to another institution, those who are noncompliant with recommended follow-up or those leaving the institution against medical advice.
• Patients referred to St. Jude for limited care on phase 1 protocol.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Group; Data Collection	Other: Data Collection; Continuing review of outcomes and late toxicities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To provide continuing review of outcome and late toxicity for all patients actively being followed or treated for childhood cancer at St. Jude Children's Research Hospital, all St Jude Alumni and all St. Life participants.	25 years

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Melissa M Hudson, MD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2000
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 22, 2008
• First Posted (Estimated): May 26, 2008

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: St. Jude Alumni; St. Jude Life Participants
• Other Study ID Numbers: SJLTFU

Drug and device information, study documents

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