Collection of Retrospective (Archival) Samples and Prospe... | NCT02239575

Studies
Collection of Retrospective (Archival) Samples and Prospective Collection of Surplus Tissue and Blood Samples

NCT02239575

Sponsor

Global BioClinical

Status

Withdrawn

Last Update Posted

Feb 28, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Feb 27, 2023Actual

First Submitted Date

Jul 16, 2014

First Submission Date that Met QC Criteria

Sep 10, 2014

First Posted Date

Sep 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Feb 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification and validation of cancer biomarkers in archival formalin fixed and paraffin embedded tumor samples	This study will identify novel cancer biomarkers associated with various solid tumor sub-types, tumor stages, and from patients with various responses to treatment.	Sample Collection May 2014 to Dec 2016, disease recurrence follow-up periods for upto 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Surplus surgical specimens from subjects diagnosed with cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Mucci	GBC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Global BioClinical		Seattle	Washington	98104	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

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Browse Branches

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