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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00900250
First received: May 9, 2009
Last updated: May 12, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Refractory Childhood Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Other: Cytology Specimen Collection 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 to up to 5 years ] [ Designated as safety issue: No ]

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 (specimen collection and baking)

Patients enrolled on 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.

Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling

Detailed Description:

OBJECTIVES:

I. 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.

II. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients With Hodgkin's Lymphoma.

Criteria

Inclusion Criteria:

  • 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)
  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 169 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Meghan Higman, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00900250     History of Changes
Other Study ID Numbers: AHOD04B1, NCI-2009-00378, COG-AHOD04B1, AHOD04B1, AHOD04B1, U10CA180886, U10CA098543
Study First Received: May 9, 2009
Last Updated: May 12, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 02, 2015