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

Breast Cancer Clinical Trial

— GBCPRT0008  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01792882
• Other study ID #: GBC PRT0008
• Status: Withdrawn
• Start date: February 2013
• Est. completion date: February 27, 2023

Study information

• Verified date: February 2023
• Source: Global BioClinical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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 to 90 Years

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Hematologic Cancer
• Hematologic Neoplasms
• Lung Cancer
• Prostate Cancer

Locations

Country	Name	City	State
United States	GBC	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Global BioClinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epigenetic modification		up to 18 months
Primary	Tumor genetic sequence variation	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.	up to 18 months
Secondary	Transcription profile		up to 18 months