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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00900250
First received: May 9, 2009
Last updated: August 5, 2014
Last verified: August 2014
  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
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hodgkin Disease (HD) Banking Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Biologic specimen repository and database [ Time Frame: baseline, prior to day 8, first response evaluation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor tissue, serum, blood


Estimated Enrollment: 1272
Study Start Date: October 2006
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative all patients

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.

Other: biologic sample preservation procedure

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
Sampling Method:   Non-Probability Sample
Study Population

Histologically confirmed Hodgkin's lymphoma

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
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: 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
Study Chair: Pedro A. de Alarcon, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00900250     History of Changes
Other Study ID Numbers: AHOD04B1, COG-AHOD04B1, CDR0000495369
Study First Received: May 9, 2009
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
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 October 19, 2014