Protocol For Collecting Data On Patients With Childhood Cancer

This study is currently recruiting participants.
Verified December 2013 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00684580
First received: May 22, 2008
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Childhood Cancer
Other: Data Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol For Collecting Data On Patients With Childhood Cancer

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 25 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: May 2000
Estimated Study Completion Date: May 2025
Estimated Primary Completion Date: May 2025 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Data Collection
Continuing review of outcomes and late toxicities

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684580

Contacts
Contact: Melissa M Hudson, MD 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Melissa M Hudson, MD    866-278-5833    info@stjude.org   
Principal Investigator: Melissa M Hudson, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Melissa M Hudson, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00684580     History of Changes
Other Study ID Numbers: SJLTFU
Study First Received: May 22, 2008
Last Updated: December 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
St. Jude Alumni
St. Jude Life Participants

ClinicalTrials.gov processed this record on April 23, 2014