Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples

NCT02239575 | Withdrawn

• 1 other identifier: GBC PRT0009
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll specimens from subjects diagnosed with various cancers and who have either:

1. 1.RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or
2. 2.PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected.

Conditions

Cancer

Keywords

Assorted cancers (oncology)

Outcome Measures

Primary Outcomes (1)

• Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples

  This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.

  Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surplus surgical specimens from subjects diagnosed with cancer

You may qualify if:

• Any adult age
• Any sex
• Able to provide consent for surplus tissue and/or blood donation
• Diagnosed with one of the cancer indications listed below:
• Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
• Have not yet received treatment for cancer

You may not qualify if:

• Not diagnosed with required cancer indication
• Not scheduled to undergo surgical resection of the tumor
• Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
• Not able to donate an adequate volume of blood to meet minimum requirements

Sponsors & Collaborators

• Global BioClinical: lead

Study Sites (1)

Global BioClinical

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

pre-surgical blood samples and/or surplus surgical oncology tissues

MeSH Terms

Conditions

Neoplasms

Study Officials

• Neil Mucci

  GBC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: September 15, 2014
• Study Start: March 1, 2014
• Primary Completion: December 31, 2022
• Study Completion: February 27, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (1)