Cancer Clinical Trial
— GBCPRT0009Official title:
Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples
| NCT number | NCT02239575 |
| Other study ID # | GBC PRT0009 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | February 27, 2023 |
| Verified date | February 2023 |
| Source | Global BioClinical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will enroll specimens from subjects diagnosed with various cancers and who have either: 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. 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. Subject clinical information will be collected, including basic demographic information, medical history, current cancer history and treatment. A final pathology report will be obtained for each subject's surgical specimen. In some instances, and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | February 27, 2023 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Global BioClinical | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Global BioClinical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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