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


N/A
18 Years
90 Years
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Hematologic Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Tumor genetic sequence variation

Outcome Description:

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.

Outcome Time Frame:

up to 18 months

Safety Issue:

No

Principal Investigator

Neil R Mucci

Investigator Role:

Study Director

Investigator Affiliation:

Global BioClinical

Authority:

United States: Institutional Review Board

Study ID:

GBCPRT0008

NCT ID:

NCT01792882

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

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

Name

Location

GBCSeattle, Washington  98104