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Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples

Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01792882
Acronym
GBCPRT0008
Enrollment
0
Registered
2013-02-15
Start date
2013-02-28
Completion date
2023-02-27
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer, Hematologic Cancer, Lung Cancer, Prostate Cancer

Brief summary

The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human cancer. The study will create a resource available to the worldwide research community that could be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. This study will be a competitive enrollment study conducted at multiple institutions.

Detailed description

This study will enroll subjects diagnosed with various cancers and who are scheduled to undergo surgical treatment. Prior to scheduled surgery, subjects will be asked to 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, family history, current cancer history and treatment. After surgery, 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.

Interventions

None listed

Sponsors

Global BioClinical
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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 CANCER INDICATIONS: 1. Bladder Cancer - Urothelial carcinoma - nonpapillary 2. Bladder Cancer - Urothelial carcinoma - papillary 3. Brain Cancer - Astrocytoma 4. Brain Cancer - Glioblastoma 5. Brain Cancer - Medulloblastoma 6. Breast Cancer - Ductal Carcinoma 7. Breast Cancer - Lobular Carcinoma 8. Cervical Cancer - Squamous Cell Carcinoma 9. Colorectal Cancer - Adenocarcinoma 10. Esophageal Cancer - Adenocarcinoma 11. Gastric Cancer 12. Head and Neck Cancer - Squamous Cell Carcinoma 13. Hematologic Cancer - Acute Lymphocytic Leukemia (ALL) 14. Hematologic Cancer - Acute Myeloid Leukemia (AML) 15. Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) 16. Hematologic Cancer - Diffuse Large B-cell Lymphoma 17. Hematologic Cancer - Multiple Myeloma (MM) 18. Hematologic Cancer - Non-Hodgkins Lymphoma (NHL) 19. Kidney Cancer - Papillary Carcinoma 20. Kidney Cancer - Renal cell Carcinoma 21. Liver Cancer - Hepatocellular Carcinoma 22. Lung Cancer - Adenocarcinoma 23. Lung Cancer - Squamous Cell Cancer 24. Melanoma 25. Pancreatic Cancer - Ductal Adenocarcinoma 26. Prostate Cancer - Adenocarcinoma 27. Sarcomas 28. Thyroid Cancer - Follicular Carcinoma 29. Thyroid Cancer - Papillary Carcinoma 30. Uterine Cancer - Endometrial Carcinoma

Design outcomes

Primary

MeasureTime frameDescription
Tumor genetic sequence variationup to 18 monthsThe specimens collected for this project will support genomic studies on the molecular basis of cancer. This study aims to collect specimens for a project that will systematically explore a spectrum of genomic changes involved in human cancer. Specifically the project will analyze DNA copy number changes, including large (on the order of chromosomal segments) and small (1,000 to 100,000 KB) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both tumor tissue and case-matched germline DNA. The suite of analysis platforms for collaborating laboratories will be applied to a common set of molecular analytes obtained from clinically annotated high-quality tumor specimens and case matched normal control specimens obtained form this specimen collection study. Initial measures critical to ensure specimen quality and qualification for subsequent analysis include confirmed histopathology and RNA integrity.

Secondary

MeasureTime frame
Transcription profileup to 18 months

Other

MeasureTime frame
Epigenetic modificationup to 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026