Collecting and Storing Biological Samples From Young Patients With Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900250
First received: May 9, 2009
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

RATIONALE: Collecting and storing samples of tumor tissue and blood from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: This laboratory study is collecting and storing samples of tissue and blood from young patients with Hodgkin's lymphoma.


Condition Intervention
Lymphoma
Other: biologic sample preservation procedure

Study Type: Observational
Official Title: Hodgkin Disease (HD) Banking Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Biologic specimen repository and database [ Designated as safety issue: No ]

Estimated Enrollment: 1272
Study Start Date: October 2006
Detailed Description:

OBJECTIVES:

  • Establish a biologic specimen repository (of tumor tissue, tissue arrays, lymphoblastoid cell lines, host DNA, tumor and host RNA, serum, and plasma) and database linked to clinical features and outcomes from well-characterized cohorts of children and young adults with Hodgkin's lymphoma.
  • Provide specimens from diagnosis, early response evaluation, completion of chemotherapy and radiotherapy, long-term follow up, and relapse to study prognostic factors for early response, relapse, long-term outcomes, and identification of new biological targets for therapy.

OUTLINE: This is a multicenter study.

Patients enrolled on Hodgkin's lymphoma (HL) therapeutic clinical trials undergo collection of tumor tissue samples at baseline and at relapse or disease progression. Serum and anticoagulated peripheral blood samples are collected at baseline, at week 1, on day 1 of course 2, after completion of chemotherapy, after completion of radiotherapy, at 1 year after diagnosis, and at relapse or disease progression.

Patients with relapsed or progressive disease who plan to enroll on HL relapse/retrieval clinical trials undergo collection of tumor tissue, serum, and anticoagulated peripheral blood samples at relapse or disease progression.

Patients enrolled more than 1 year after completion of treatment undergo collection of tumor specimens, serum, and anticoagulated peripheral blood samples at time of clinical evaluation.

PROJECTED ACCRUAL: A total of 1,272 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma (HL) meeting 1 of the following criteria:

    • Newly diagnosed, untreated HL (for patients under 22 years of age)
    • Past or present diagnosis of HL and past or present enrollment on a Children's Oncology Group (COG) or legacy HL clinical trial (for patients of any age)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900250

  Show 154 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Meghan Higman, MD, PhD Women & Children's Hospital of Buffalo
Investigator: Pedro A. de Alarcon, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00900250     History of Changes
Other Study ID Numbers: CDR0000495369, COG-AHOD04B1
Study First Received: May 9, 2009
Last Updated: November 22, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014