Clinical trial NCT02239575: Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples
Official title: Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: Assorted cancers (oncology)
Lead sponsor: Global BioClinical
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surplus surgical specimens from subjects diagnosed with cancer

Brief summary: This study will enroll specimens from subjects diagnosed with various cancers and who have either:

1. RETROSPEFCTIVE / ARCHIVAL SAMPLES already undergone surgical resection of their tumor and have one or more formalin fixed and paraffin embedded (FFPE) blocks on file within the local (or affiliated) pathology archive (replicate blocks from same tumor) or blocks no longer required to be maintained on file - discard blocks, or
2. PROSPECTIVE SAMPLES are scheduled to undergo surgical treatment and who prior to scheduled surgery, provide informed consent and 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, current cancer history and treatment. 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.

Detailed description: CANCER INDICATIONS:

Bladder Cancer - Urothelial carcinoma - nonpapillary Bladder Cancer - Urothelial carcinoma - papillary Brain Cancer - Astrocytoma Brain Cancer - Glioblastoma Brain Cancer - Medulloblastoma Breast Cancer - Ductal Carcinoma Breast Cancer - Lobular Carcinoma Cervical Cancer - Squamous Cell Carcinoma Colorectal Cancer - Adenocarcinoma Esophageal Cancer - Adenocarcinoma Gastric Cancer Head and Neck Cancer - Squamous Cell Carcinoma Hematologic Cancer - Acute Lymphocytic Leukemia (ALL) Hematologic Cancer - Acute Myeloid Leukemia (AML) Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL) Hematologic Cancer - Diffuse Large B-cell Lymphoma Hematologic Cancer - Multiple Myeloma (MM) Hematologic Cancer - Non-Hodgkins Lymphoma (NHL) Kidney Cancer - Papillary Carcinoma Kidney Cancer - Renal cell Carcinoma Liver Cancer - Hepatocellular Carcinoma Lung Cancer - Adenocarcinoma Lung Cancer - Squamous Cell Cancer Melanoma Pancreatic Cancer - Ductal Adenocarcinoma Prostate Cancer - Adenocarcinoma Sarcomas Thyroid Cancer - Follicular Carcinoma Thyroid Cancer - Papillary Carcinoma Uterine Cancer - Endometrial Carcinoma

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

Primary outcomes:
measure: Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples
timeFrame: Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Global BioClinical
state: Washington
Study officials:
affiliation: GBC
name: Neil Mucci
role: STUDY_DIRECTOR
References: