Long Term Retention of Protspectively Obtained Biospecimens

Cancer Clinical Trial

Official title:

Long-Term Retention of Prospectively Obtained Biospecimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810431
• Other study ID #: 999912029
• Secondary ID: 12-C-N029
• Status: Completed
• Start date: December 22, 2011
• Est. completion date: May 4, 2018

Study information

• Verified date: May 4, 2018
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

This protocol is designed to have samples from closing protocols transferred to this protocol for long-term storage. The protocol is concerned with the retention of blood, plasma, serum, CSF, aspirates, bone marrow, ascites fluid, urine, saliva, PBMCs, skin, mucosal, tumor and healthy tissue samples from patients with cancer to support basic science and clinical research activities of the Medical Oncology Branch and other intramural Laboratories and Branches at the NIH Clinical Research Center and Center for Cancer Research.

Objectives:

To allow long-term storage of biospecimens collected during prospective clinical trials in patients with various cancer phenotypes, as needed to support the research activities of the Medical Oncology Branch and other Laboratories and Branches.

Eligibility:

Samples eligible for long-term retention must be from those who have signed consent for storage and retention of biospecimens.

Design:

Acquired samples will be barcoded and associated data will be entered into an encrypted computer software system, and securely maintained to protect patient identifiers. Samples are retained and made available to the original PI, or other Investigators with the original PI's permission, following submission and approval of a supplemental research protocol to the IRB or OHSRP.

Description:

Background:

This protocol is designed to have samples from closing protocols transferred to this protocol for long-term storage. The protocol is concerned with the retention of blood, plasma, serum, CSF, aspirates, bone marrow, ascites fluid, urine, saliva, PBMCs, skin, mucosal, tumor and healthy tissue samples from patients with cancer to support basic science and clinical research activities of the Genitourinary Malignancies Branch (GMB) and other intramural Laboratories and Branches at the NIH Clinical Research Center and Center for Cancer Research.

Objectives:

To allow long-term storage of biospecimens collected during prospective clinical trials in patients with various cancer phenotypes, as needed to support the research activities of the Genitourinary Malignancies Branch (GMB) and other Laboratories and Branches.

Eligibility:

Samples eligible for long-term retention must be from those who have signed consent for storage and retention of biospecimens.

Design:

Acquired samples will be barcoded and associated data will be entered into an encrypted computer software system, and securely maintained to protect patient identifiers. Samples are retained and made available to the original Principal Investigator (PI), or other investigators with the original PI's permission, following submission and approval of a supplemental research protocol to the IRB or OHSRP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• INCLUSION CRITERIA:

Patient volunteers or Legally Authorized Representative (LAR) must have signed a consent on a previously IRB approved protocol for storing biospecimens for future research.

Age is greater than or equal to 18 years of age.

EXCLUSION CRITERIA:

Related Conditions & MeSH terms

• Benign Neoplasms
• Cancer
• Carcinogens
• Neoplasms
• Tumor

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI), 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To conduct long-term storage of biospecimens collected duringprospective clinical trials.		5 years