Trial record 2 of 8 for:    cog registry

Project: Every Child for Younger Patients With Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT02402244
First received: March 25, 2015
Last updated: March 27, 2015
Last verified: March 2015
  Purpose

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.


Condition Intervention
Central Nervous System Neoplasm
Childhood Lymphoma
Childhood Relapsed Solid Tumor
Other: cytology specimen collection procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • medical chart review [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Preservation of clinically annotated, adequately preserved biological specimens for future research efforts


Biospecimen Retention:   Samples With DNA

tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine


Estimated Enrollment: 33000
Study Start Date: June 2015
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (Project: Every Child)
Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine).
Other: cytology specimen collection procedure
Undergo cytology specimen collection
Other Name: cytologic sampling

Detailed Description:

PRIMARY OBJECTIVES:

I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline deoxyribonucleic acid (DNA); and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions.

IV. To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.

OUTLINE:

Patients undergo medical data review to create a Childhood Cancer Registry. Patients also undergo collection of bio-specimen samples (e.g., tissue, blood, bone marrow, plasma, serum, buccal cells, saliva, cerebrospinal fluid, or urine).

  Eligibility

Ages Eligible for Study:   up to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with relapsed solid tumors, lymphomas and Central Nervous System (CNS) tumors.

Criteria

Inclusion Criteria:

  • Enrollment can occur at any time after disease presentation including at time of disease progression or recurrence; for patients who are to be enrolled on COG therapeutic studies, enrollment on APEC14B1 must occur prior to enrollment onto the therapeutic trial
  • Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:

    • All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
    • All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
    • Other benign/borderline conditions including:

      • Mesoblastic nephroma
      • Teratomas
      • Myeloproliferative diseases including transient myeloproliferative disease
      • Langerhan cell histiocytosis
      • Lymphoproliferative diseases
  • Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network (NCTN) ) therapeutic study, for whom there is a higher upper age limit
  • All patients or their parents or legally authorized representatives must sign a written informed consent; parents will be asked to sign a separate consent for their own biospecimen submission
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02402244

Locations
United States, Pennsylvania
Children's Oncology Group Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Peter C. Adamson, MD    215-590-6359    adamson@email.chop.edu   
Principal Investigator: Peter C. Adamson, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Peter Adamson, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT02402244     History of Changes
Other Study ID Numbers: APEC14B1, NCI-2014-02057, APEC14B1, APEC14B1, U10CA098543
Study First Received: March 25, 2015
Last Updated: March 27, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2015