Trial record 1 of 2 for:    AOST06B1
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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

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:
NCT00899275
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 to test in the laboratory may help the study of cancer in the future.

PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.


Condition Intervention
Sarcoma
Other: biologic sample preservation procedure

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Collect biological specimens from patients with osteosarcoma [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Provide a repository for long-term storage of osteosarcoma-related biological materials [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Make these specimens available to qualified researchers to understand the biology of osteosarcoma [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Correlate these results with the patients' clinical data [ Time Frame: lengh of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, plasma and blood


Estimated Enrollment: 1000
Study Start Date: February 2008
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary/Correlative All patients Other: biologic sample preservation procedure

Detailed Description:

OBJECTIVES:

  • To collect biological specimens from patients with osteosarcoma at Children's Oncology Group (COG) institutions.
  • To provide a repository for long-term storage of osteosarcoma-related biological materials.
  • To make these specimens available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patients' clinical data.

OUTLINE: After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material. Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples). Autopsy tumor samples may also be submitted.

  Eligibility

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

All osteosarcoma patients seen at COG institutions

Criteria

DISEASE CHARACTERISTICS:

  • All osteosarcoma patients seen at COG institutions are eligible, including the following:

    • Newly diagnosed patients
    • Patients with recurrent disease who were not enrolled at the time of diagnosis
  • The following specimens from the initial biopsy (and/or definitive surgery if an up-front resection is performed) are required:

    • Paraffin embedded block OR 30 unstained slides
    • Pretreatment blood consisting of 5 mL serum, 10 mL plasma, and 10 mL heparinized whole blood
    • Fresh and frozen tumor specimens

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Patients are not required to enter a therapeutic study to enroll on this study
  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: NCT00899275

  Show 155 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Richard Gorlick, MD Children's Hospital at Montefiore
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899275     History of Changes
Other Study ID Numbers: AOST06B1, COG-AOST06B1, CDR0000562538
Study First Received: May 9, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Oncology Group:
osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on October 01, 2014