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

Withdrawn

• Conditions: Breast Cancer; Hematologic Cancer; Colorectal Cancer; Prostate Cancer; Lung Cancer

• Registration Number: NCT01792882
• Lead Sponsor: Global BioClinical

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Primary Completion: 2022-12-31
• Status Verified: 2023-02
• Study Completion: 2023-02-27
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor genetic sequence variation	up to 18 months	The 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 Outcome Measures

Name	Time	Method
Transcription profile	up to 18 months

Trial Locations

Locations (1)

GBC; 🇺🇸 Seattle, Washington, United States