Collecting and Storing Biological Samples From Young Pati... | NCT00900250

ID	Type	Description	Link
NCI-2009-00378	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CDR0000495369
COG-AHOD04B1
AHOD04B1	Other Identifier	Childrens Oncology Group
AHOD04B1	Other Identifier	CTEP
U10CA180886	U.S. NIH Grant/Contract		View source
U10CA098543	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2006Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

May 9, 2009

First Submission Date that Met QC Criteria

May 9, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2019

Last Update Posted Date

Apr 10, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,271Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytology Specimen Collection Procedure	Other	Correlative studies	Ancillary-correlative (specimen collection and baking)

Measure	Description	Time Frame
Biologic specimen repository and database		Baseline to up to 5 years

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients newly diagnosed with HL or patients with HL enrolled (past or present) on COG or legacy HL clinical trials

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Alabama		Birmingham	Alabama	35233	United States
University of Alabama at Birmingham Cancer Center