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Study of Evaluation and Treatment of Patients With Cancer or Precancerous Conditions

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of Patients With Cancer or Precancerous Conditions

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Active 3 months to 40 years NCI NCI-98-C-0037
NCT00445536

Special Category: NIH Clinical Center trial

Objectives

To follow and evaluate patients, longitudinally with cancer or precancerous conditions referred to the NIH Clinical Center Pediatric Oncology Branch who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific importance.
To allow, when clinically indicated, patients to receive standard care therapies.

Entry Criteria

Disease Characteristics:

Diagnosis of cancer or precancerous condition

Meets the following criteria:
- Present with disease manifestations of special interest to NIH Clinical Center Pediatric Oncology Branch (POB) including, but not limited to, any of the following:
  - Lymphoma
  - Brain tumors
  - Ewings sarcoma
  - Leukemia
  - Neuroectodermal tumors
  - Osteosarcoma
  - Rhabdomyosarcoma
    - Patients between 30-40 years of age are only eligible if their condition is of specific interest to the POB

Prior/Concurrent Therapy:

Concurrent radiotherapy, surgery, or other medical treatment allowed

Patient Characteristics:

Not specified

Expected Enrollment

250

A total of 250 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Natural history of disease

Outline

Patients are evaluated at least every 3-6 months for up to 3 years and receive standard care as prescribed. Demographic information, histology, pathologic findings, and laboratory and imaging parameters are collected during that time. Blood, urine, or tumor specimens may be collected. Patients undergo periodic diagnostic x-rays and/or nuclear medicine scans.

Previous medical care data will be obtained and entered into a database.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Crystal Mackall, MD, Protocol chair
Ph: 301-402-5940

Trial Sites

U.S.A.

Maryland

Bethesda

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Patient Recruitment
Ph: 888-NCI-1937

Registry Information

Official Title		Treatment of Children with Cancer

Trial Start Date		1998-11-03

Registered in ClinicalTrials.gov		NCT00445536

Date Submitted to PDQ		1997-12-09

Information Last Verified		2008-04-15

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.