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Protocol For Collecting Data On Patients With Childhood Cancer

Open (Enrolling)
Childhood Cancer

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Trial Information

Protocol For Collecting Data On Patients With Childhood Cancer

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

25 years

Safety Issue:


Principal Investigator

Melissa M Hudson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

May 2000

Completion Date:

May 2025

Related Keywords:

  • Childhood Cancer
  • St. Jude Alumni
  • St. Jude Life Participants



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794