The STRIVE Study: Breast Cancer Screening Cohort

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

GRAIL, Inc.

ClinicalTrials.gov Identifier:

NCT03085888

First received: January 17, 2017

Last updated: May 25, 2017

Last verified: May 2017

History of Changes

Purpose

GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to train and validate an assay to detect invasive breast cancer in patients undergoing mammography.

Condition
Invasive Breast Cancer Neoplasm, Breast Cancer, Breast


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Other Time Perspective: Prospective
Target Follow-Up Duration:	5 Years
Official Title:	The STRIVE Study: Breast Cancer Screening Cohort for Training and Validation of the GRAIL Test

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by GRAIL, Inc.:

Primary Outcome Measures:

Diagnosis of invasive breast cancer among women undergoing mammography [ Time Frame: 30 Months Estimated ]
Clinically annotated plasma samples from participants will undergo high-intensity sequencing to characterize cfNA profiles.


Estimated Enrollment:	120000
Actual Study Start Date:	February 28, 2017
Estimated Study Completion Date:	May 2025
Estimated Primary Completion Date:	July 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts
Prospective Cohort This is a prospectively enrolling cohort study with a pre-specified molecular analysis plan. A stratified case-cohort design will be employed to select cancer cases and non-cancer subjects who will be assayed. All cases of cancer (breast and non-breast cancer) will be selected. A random subset of the overall study cohort will also be selected.

Detailed Description:

Detection of early stage cancer may be possible through analysis of circulating cell-free nucleic acids (cfNAs) shed into the blood by tumors. GRAIL is using high-intensity sequencing (based on broad genomic coverage and deep sequencing) of cfNAs, combined with machine learning, to develop blood tests to detect cancer early. The purpose of this prospective, multi-center, observational cohort study is to train and validate an assay for the early detection of breast cancer. The study will collect blood samples from participants within 28 days of their screening mammogram. For participants who receive a cancer diagnosis during the study, tissue samples will be collected.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

This study seeks to enroll 120,000 women receiving screening mammography and associated medical care from participating study centers.

Criteria

Inclusion Criteria:

Patient has an appointment for screening mammography, as referred or recommended by a health care provider.
Screening mammogram is received at same facility within 28 days of blood draw (i.e. blood may be drawn up to 28 days before or 28 days after the screening mammogram).
Provides informed consent in English or Spanish. Understands the protocol and its requirements, risks, and discomforts.
Provides consent to participate in long-term follow-up, such as contact via study portal, mail, or phone, for further self-reported information regarding cancer diagnoses, change to health plan or residential status, or request for additional blood draws and linkage to state state cancer registries and administrative databases.

Exclusion Criteria:

Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
Breast biopsy to evaluate abnormal breast imaging results has occurred prior to a planned research blood draw.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03085888

Locations


United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
Sutter Health California Pacific Medical Center
San Francisco, California, United States, 94118
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic - Minnesota
Rochester, Minnesota, United States, 32224
United States, Wisconsin
Mayo Clinic
La Crosse, Wisconsin, United States, 54601

Sponsors and Collaborators

GRAIL, Inc.

Investigators


Study Director:	Brian Allen, MS	GRAIL, Inc.
Study Director:	Anne-Renee Hartman, MD	GRAIL, Inc.

More Information


Responsible Party:	GRAIL, Inc.
ClinicalTrials.gov Identifier:	NCT03085888 History of Changes
Other Study ID Numbers:	GRAIL-002
Study First Received:	January 17, 2017
Last Updated:	May 25, 2017
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by GRAIL, Inc.:


Cancer Screening Next Generation Sequencing Circulating cell-free nucleic acid Circulating cell-free tumor DNA Deep sequencing

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on June 26, 2017

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