Study of Patients With Cancer or Precancerous Conditions - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445536

Purpose

RATIONALE: Following the course of disease in patients with cancer or precancerous conditions who are receiving standard care may help the study of cancer in the future.

PURPOSE: This natural history study is looking at the course of disease in patients with cancer or precancerous conditions.

Condition	Intervention
Brain and Central Nervous System Tumors Leukemia Lymphoma Neuroblastoma Precancerous/Nonmalignant Condition Sarcoma Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Procedure: medical chart review Procedure: observation

MedlinePlus related topics: Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Neuroblastoma Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Observational
Official Title:	Treatment of Children With Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Natural history of disease [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	November 1998

Detailed Description:

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.

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.

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

Eligibility

Ages Eligible for Study:	up to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Concurrent radiotherapy, surgery, or other medical treatment allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445536

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Crystal Mackall, MD

NCI - Pediatric Oncology Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000078581, NCI-98-C-0037
Study First Received:	March 7, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00445536
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
precancerous/nonmalignant condition
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma

stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma

Study placed in the following topic categories:

Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Malignant mesenchymal tumor
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Lymphomatoid granulomatosis
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Leukemia, Prolymphocytic
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Neuroepithelioma
Rhabdomyosarcoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Astrocytoma
Leukemia, Myelomonocytic, Chronic
Acute myelogenous leukemia
Leukemia, Myeloid
Brain Neoplasms
Waldenstrom Macroglobulinemia
Leukemia, Myeloid, Accelerated Phase
Sarcoma
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Neoplasms, Glandular and Epithelial
Choroid Plexus Neoplasms
Precancerous Conditions

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases

Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009