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Evaluation, Treatment, and Natural History of Children With Cancer

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001686
First Posted: November 4, 1999
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
This protocol is designed to evaluate children with cancer who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific importance or educational value.

Condition
Ewing's Sarcoma Leukemia Lymphoma Brain Tumors Rhabdomyosarcoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Treatment of Children With Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Standard of care [ Time Frame: Ongoing ]

Enrollment: 408
Study Start Date: December 3, 1997
Groups/Cohorts
1
Standard of Care

Detailed Description:

Background:

Children are referred to the Pediatric Oncology Branch (POB) for possible enrollment in clinical protocols for the treatment of cancer. While some children are not eligible for a specific protocol, they may present with disease manifestations that offer the potential for important new insights into the pathogenesis or clinical behavior of their underlying disease. In addition, children who have completed participation in a clinical protocol but do not currently have therapeutic protocol alternatives may continue to provide POB with important information. Diseases of interest to the POB include, but are not limited to lymphoma, brain tumors, Ewings sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, and rhabdomyosarcoma. Hence, serial clinical evaluation of such patients, including the performance of clinical, laboratory, and diagnostic studies to help elucidate longitudinally the underlying disease mechanisms, and when clinically indicated standard care therapies, will assist POB meet its overall mission.

Objectives:

To be able to follow and evaluate children with cancer or pre-cancer syndromes referred to the Pediatric Oncology Branch who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific import.

Eligibility:

Patients who are evaluated by the Pediatric Oncology Branch and are: Children with cancer (or a pre-cancer syndrome), between the age(s) of 3 months - 40 years who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, because they are likely to shed led light on disease pathogenesis or the clinical behavior of the disorder. Patients between the ages of 30 and 40 years may be evaluated on this protocol if their cancer (or pre-cancer syndrome) is of specific interest to the Pediatric Oncology Branch.

Design:

The medical procedures or tests will be selected for each patient on the basis of his/her individual diagnosis (or presumed diagnosis). When clinically indicated, standard therapy will be administered and patients will be followed according to standard medical practice. Specimens may be collected for clinical care purposes only to evaluate the patient s status.

No investigational tests, drugs or therapies will be administered in this protocol.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients who are evaluated by the Pediatric Oncology Branch and are:

Children with cancer (or a precancer syndrome), between the age(s) of 3 months to 40 years.

Patients between the ages of 30 and 40 years may be evaluated on this protocol if their cancer (or precancer syndrome) is of specific interest to the Pediatric Oncology Branch.

Patients with cancer (or a precancer syndrome), who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, including but not limited to, lymphoma, brain tumors, Ewings sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, rhabdomysarcoma.

If indicated, availability of a parent or legal guardian to give informed consent.

Patients, and, when indicated, parent or legal guardian who are deemed sufficiently reliable to return for recommended follow-up visits.

Patients greater than or equal to 18 years of age must be able to give informed consent.

EXCLUSION CRITERIA:

Patients younger than 3 months of age.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001686


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brigitte C Widemann, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00001686     History of Changes
Obsolete Identifiers: NCT00445536
Other Study ID Numbers: 980037
98-C-0037
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: November 24, 2017
Last Verified: November 13, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Leukemia
Ewing's Sarcoma
Neuroectodermal Tumors
Osteosarcoma Lymphoma
Rhabdomyosarcoma Brain Tumors
Lymphoma
Neoplasm
Sarcoma

Additional relevant MeSH terms:
Sarcoma
Brain Neoplasms
Rhabdomyosarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Myosarcoma
Neoplasms, Muscle Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue