Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Breast Cancer Clinical Trial

Official title:

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662204
• Other study ID #: 2018-01
• Status: Completed
• Start date: August 23, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: Exact Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Description:

Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5133
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.

OR

Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.

3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Prior or concurrent cancer diagnosis defined as:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR

2. Recurrence of the same primary cancer within any timeframe; OR

3. Concurrent diagnosis of multiple primary cancers

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Esophageal Cancer
• Kidney Cancer
• Kidney Neoplasms
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pelvic Neoplasms
• Prostate Cancer
• Renal Pelvis Cancer
• Stomach Cancer
• Stomach Neoplasms
• Uterine Cancer
• Uterine Neoplasms

Intervention

Other:
• Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	PMG Research of McFarland Clinic	Ames	Iowa
United States	University Cancer & Blood Center, LLC	Athens	Georgia
United States	Piedmont Cancer Institute, PC	Atlanta	Georgia
United States	RMR VA Medical Center	Aurora	Colorado
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Beverly Hospital, Oncology	Beverly	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	PMG Research of Bristol, LLC	Bristol	Tennessee
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Seattle Urology Research Center	Burien	Washington
United States	Hematology & Oncology Associates, Inc.	Canton	Ohio
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Charleston Cancer Center	Charleston	South Carolina
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	John Muir Clinical Research	Concord	California
United States	Christus Spohn Cancer Center	Corpus Christi	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Des Moines Oncology Research Associate	Des Moines	Iowa
United States	PMG Research of DuPage Medical Group	Downers Grove	Illinois
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care Research	Edgewood	Kentucky
United States	McLeod Center for Cancer Treatment and Research	Florence	South Carolina
United States	Southeast Florida Hematology-Oncology Group, PA	Fort Lauderdale	Florida
United States	Mercy Research-Fort Smith	Fort Smith	Arkansas
United States	Cancer and Hematology Centers of Western Michigan, PC	Grand Rapids	Michigan
United States	Cancer Research Consortium of West Michigan (CRCWM)	Grand Rapids	Michigan
United States	HSHS St. Vincent Hospital	Green Bay	Wisconsin
United States	Marin Cancer Care	Greenbrae	California
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Saint Francis Cancer Center Research Department	Greenville	South Carolina
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	University of Texas Health Science Center	Houston	Texas
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	St. Dominic's Gynecologic Oncology	Jackson	Mississippi
United States	The Jackson Clinic	Jackson	Tennessee
United States	CSNF - Central Business Office	Jacksonville	Florida
United States	Michael Berry Building-Oncology	Janesville	Wisconsin
United States	Presence Cancer Care / JOHA	Joliet	Illinois
United States	NEA Fowler Family Center for Cancer Care	Jonesboro	Arkansas
United States	Mercy Cancer Center	Joplin	Missouri
United States	Jupiter Medical Center	Jupiter	Florida
United States	Alliance Research Centers	Laguna Hills	California
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	Baptist Health-Lexington	Lexington	Kentucky
United States	Nebraska Hematology-Oncology -- Lincoln	Lincoln	Nebraska
United States	Somnos Laboratories, Inc.	Lincoln	Nebraska
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Baptist Health	Louisville	Kentucky
United States	Norton Cancer Institute-Pavilion	Louisville	Kentucky
United States	Lowell General Hospital	Lowell	Massachusetts
United States	UW Carbone Cancer Center	Madison	Wisconsin
United States	Tri-County Hematology & Oncology Associates, Inc.	Massillon	Ohio
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	The Minniti Center for Hematology and Oncology	Mickleton	New Jersey
United States	Middlesex Hospital	Middletown	Connecticut
United States	Mon Health Medical Center	Morgantown	West Virginia
United States	West Virginia University Cancer Institute	Morgantown	West Virginia
United States	Office of John Homan, MD	Newport Beach	California
United States	Lowcountry Urology/PMG Research of Charleston, LLC	North Charleston	South Carolina
United States	Easter Ct Hematology and Oncology	Norwich	Connecticut
United States	North County Oncology	Oceanside	California
United States	Community Cancer Trials of Utah	Ogden	Utah
United States	Genie Jackson Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Mercy Oncology Research	Oklahoma City	Oklahoma
United States	UCI Department of Urology	Orange	California
United States	Mid Florida Hematology and Oncology Center	Orange City	Florida
United States	Baptist Health- Paducah	Paducah	Kentucky
United States	Illinois CancerCare, P.C.	Peoria	Illinois
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division	Poughkeepsie	New York
United States	Women & Infants Hospital	Providence	Rhode Island
United States	RH Clinical Research	Rapid City	South Dakota
United States	Riverview Medical Center	Red Bank	New Jersey
United States	Cancer Care Specialists	Reno	Nevada
United States	Virginia Cancer Institute	Richmond	Virginia
United States	PMG Research of Rocky Mount	Rocky Mount	North Carolina
United States	Adventist Health - Saint Helena Hospital	Saint Helena	California
United States	Mercy Hospital	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Metro-Minnesota Community Oncology Research Consortium (MMCORC)	Saint Louis Park	Minnesota
United States	Park Nicollet Institute - Oncology Research	Saint Louis Park	Minnesota
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	St. Joseph Heritage Healthcare	Santa Rosa	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Candler Hospital	Savannah	Georgia
United States	Scottsdale Medical Imaging Research	Scottsdale	Arizona
United States	Holy Cross Hospital Resource Center Department of Cancer Research	Silver Spring	Maryland
United States	Orchard Healthcare Reasearch Inc	Skokie	Illinois
United States	Ascension Providence Hospitals	Southfield	Michigan
United States	Spartanburg Medical Center: Gibbs Cancer Center & Research Institute	Spartanburg	South Carolina
United States	Mercy Cancer and Hematology Clinic	Springfield	Missouri
United States	SIU School of Medicine	Springfield	Illinois
United States	Stamford Hospital	Stamford	Connecticut
United States	Richmond University Medical Center	Staten Island	New York
United States	PMG Research of Piedmont	Statesville	North Carolina
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Associated Medical Professionals	Syracuse	New York
United States	MultiCare Regional Cancer Center	Tacoma	Washington
United States	Cancer Treatment Center	Texarkana	Texas
United States	Renovatio Clinical	The Woodlands	Texas
United States	Lewis Hall Singletary Oncology Center	Thomasville	Georgia
United States	Arizona Clinical Research Center, Inc.	Tucson	Arizona
United States	Urological Associates of Southern Arizona, PC	Tucson	Arizona
United States	North Mississippi Medical Center Hematology and Oncology	Tupelo	Mississippi
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Marion L. Shepard Cancer Center	Washington	North Carolina
United States	ProHealth Care Research Institute	Waukesha	Wisconsin
United States	Lexington Medical Center	West Columbia	South Carolina
United States	Innovative Clinical Research Institute	Whittier	California
United States	Zimmer Cancer Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Evaluation	Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.	Point in time (one day) blood collection at enrollment