Trial record 1 of 1 for:
NCT03085888
The STRIVE Study: Breast Cancer Screening Cohort
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03085888 |
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Recruitment Status
:
Enrolling by invitation
First Posted
: March 21, 2017
Last Update Posted
: April 19, 2018
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Sponsor:
GRAIL, Inc.
Information provided by (Responsible Party):
GRAIL, Inc.
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Brief Summary:
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 or disease |
|---|
| Invasive Breast Cancer Neoplasm, Breast Cancer, Breast |
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. Additional blood samples will also be collected for a subset of participants. For participants who receive a cancer diagnosis during the study, tissue samples will be collected.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 120000 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection |
| Actual Study Start Date : | February 28, 2017 |
| Estimated Primary Completion Date : | July 2019 |
| Estimated Study Completion Date : | May 2025 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
| Group/Cohort |
|---|
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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.
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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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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 undergoing mammography for screening indications and associated medical care from participating study centers.
Criteria
Inclusion Criteria:
- Women undergoing mammography for screening indications or have an appointment for screening mammography.
- Participant provides informed consent and expresses understanding of the protocol and its requirements, risks, and discomforts.
Exclusion Criteria:
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085888
Locations
| United States, Arizona | |
| Mayo Clinic Arizona | |
| Phoenix, Arizona, United States, 85054 | |
| Scottsdale Medical Imaging - Town Center | |
| Scottsdale, Arizona, United States, 85251 | |
| Scottsdale Medical Imaging - Thompson Peak | |
| Scottsdale, Arizona, United States, 85255 | |
| Scottsdale Medical Imaging - Sue Levy Breast Center | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Sutter Imaging Elk Grove | |
| Elk Grove, California, United States, 95758 | |
| Sutter Imaging Folsom II | |
| Folsom, California, United States, 95630 | |
| Sutter Palo Alto Medical Foundation Mountain View Breast Center | |
| Mountain View, California, United States, 94040 | |
| Carol Ann Read Breast Health Center | |
| Oakland, California, United States, 94609 | |
| Palo Alto Medical Foundation Research Institute | |
| Palo Alto, California, United States, 94301 | |
| Sutter Imaging Roseville Parkway | |
| Roseville, California, United States, 95661 | |
| Sutter Imaging Sacramento | |
| Sacramento, California, United States, 95816 | |
| Sutter Health California Pacific Medical Center | |
| San Francisco, California, United States, 94118 | |
| Mills-Peninsula Medical Center | |
| San Mateo, California, United States, 94401 | |
| Sutter Health -Palo Alto Medical Foundation | |
| Santa Cruz, California, United States, 95062 | |
| Sutter Pacific Medical Foundation | |
| Santa Rosa, California, United States, 95403 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Kansas | |
| Menorah Medical Center | |
| Overland Park, Kansas, United States, 66209 | |
| United States, Minnesota | |
| Mayo Clinic - Minnesota | |
| Rochester, Minnesota, United States, 32224 | |
| United States, Missouri | |
| Centerpoint Medical Center | |
| Independence, Missouri, United States, 64057 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Tristar Summit Outpatient Center Summit Women's Imaging | |
| Hermitage, Tennessee, United States, 37076 | |
| Tristar Centennial Women's Health and Imaging Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Virginia | |
| Henrico Doctor's Hospital | |
| Richmond, Virginia, United States, 23229 | |
| CJW Medical Center | |
| Richmond, Virginia, United States, 23235 | |
| Lewis Gale Medical Center | |
| Salem, Virginia, United States, 24153 | |
| United States, Wisconsin | |
| Mayo Health Systems | |
| Eau Claire, Wisconsin, United States, 54702 | |
| 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. |
| Responsible Party: | GRAIL, Inc. |
| ClinicalTrials.gov Identifier: | NCT03085888 History of Changes |
| Other Study ID Numbers: |
GRAIL-002 |
| First Posted: | March 21, 2017 Key Record Dates |
| Last Update Posted: | April 19, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |