Clinical trial NCT01792882: Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
Official title: Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Hematologic Cancer
Lead sponsor: Global BioClinical
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with one of the cancer indications listed below and scheduled to undergo surgical tumor resection

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor genetic sequence variation
timeFrame: up to 18 months
Secondary outcomes:
measure: Transcription profile
timeFrame: up to 18 months
Other outcomes:
measure: Epigenetic modification
timeFrame: up to 18 months
Locations:
city: Seattle
country: United States
facility: GBC
state: Washington
Study officials:
affiliation: Global BioClinical
name: Neil R Mucci
role: STUDY_DIRECTOR
References: