NeoplasmsNCT03085888
The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types
An observational study of Neoplasms and Cancer, run by GRAIL, Inc. at 35 sites in United States.
Trial 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 validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- How many people
- 99,481 participants
- Where
- 35 sitesUnited States
- Study dates
- 28 Feb 2017to 1 Apr 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This multi-center study aims to enroll approximately 100,000 women undergoing mammography for screening indications and associated medical care from participating study centers.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Cleveland Clinic
Avon, Ohio, 44011
Cleveland Clinic
Beachwood, Ohio, 44122
Sarah Cannon Research Institute
Charleston, South Carolina, 29406
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Dearborn, Michigan, 48126
Henry Ford Health System
Detroit, Michigan, 48202
Mayo Clinic
Eau Claire, Wisconsin, 54702
Sutter Health
Elk Grove, California, 95758
Sutter Health
Folsom, California, 95630
Henry Ford Health System
Grosse Pointe Farms, Michigan, 48326
Sarah Cannon Research Institute
Hermitage, Tennessee, 37076
Sarah Cannon Research Institute
Independence, Missouri, 64057
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
La Crosse, Wisconsin, 54601
Henry Ford Health System
Livonia, Michigan, 48150
Sarah Cannon Research Institute
McKinney, Texas, 75069
Sutter Health
Mountain View, California, 94040
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Sutter Health
Oakland, California, 94609
Sarah Cannon Research Institute
Overland Park, Kansas, 66209
Sutter Health
Palo Alto, California, 94301
Mayo Clinic
Phoenix, Arizona, 85054
Sarah Cannon Research Institute
Richmond, Virginia, 23229
Sarah Cannon Research Institute
Richmond, Virginia, 23235
Mayo Clinic
Rochester, Minnesota, 32224
Sutter Health
Roseville, California, 95661
Sutter Health
Sacramento, California, 95816
Sarah Cannon Research Institute
Salem, Virginia, 24153
Sarah Cannon Research Institute
Salt Lake City, Utah, 84124
Sutter Health
San Francisco, California, 94118
Sutter Health
San Mateo, California, 94401
Sutter Health
Santa Cruz, California, 95062
Sutter Health
Santa Rosa, California, 95403
Scottsdale Medical Imaging Research
Scottsdale, Arizona, 85258
Sarah Cannon Research Institute
Snellville, Georgia, 30078
About this study
Official title: The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
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 validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.
Read the 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 validate an assay for the early detection of breast cancer and other invasive cancers, including hematologic malignancies. 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, archival tissue samples will be collected.
- Keywords
- Cancer Screening, High-Throughput Nucleotide Sequencing, Deep Sequencing, Circulating cell-free tumor DNA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
Measured: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
To refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers (including hematologic malignancies).
Measured: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Secondary outcomes (2)
Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in To evaluate the performance of the GRAIL Test to detect invasive cancers in clinically meaningful subgroups.
sequencing to characterize cfNA profiles.
Measured: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in 6-month time windows (e.g. 0-6 months, >6-12 months, >12-18 months, >18-24 months).
Measured: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start28 Feb 2017
- Primary completion30 Jun 2022
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 99,481 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- GRAIL, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GRAIL Study Director, Study director, GRAIL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085888
- Sponsor's protocol ID
- GRAIL-002
- Status last verified
- Sep 2024
- First submitted
- 17 Jan 2017
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
PubMed 33506766
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection
- ClinicalTrials.gov ID
- NCT03085888
- Acronym / sponsor ID
- GRAIL-002
- Keywords
- Cancer Screening, High-Throughput Nucleotide Sequencing, Deep Sequencing, Circulating cell-free tumor DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,481 participants (actual)
- Lead sponsor
- GRAIL, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 validate the ability of the pre-specified GRAIL Test to detect breast cancer and other invasive cancers, including hematologic malignancies, that will occur within one year of the first study blood draw.
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 validate an assay for the early detection of breast cancer and other invasive cancers, including hematologic malignancies. 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, archival tissue samples will be collected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This multi-center study aims to enroll approximately 100,000 women undergoing mammography for screening indications and associated medical care from participating study centers.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies).
Time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
To refine the predictive algorithms and cut points of the GRAIL test to detect breast and other invasive cancers (including hematologic malignancies).
Time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
2 secondary outcomes
Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in To evaluate the performance of the GRAIL Test to detect invasive cancers in clinically meaningful subgroups.
Time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Diagnosis of invasive cancers, including hematologic malignancies, diagnosed in 6-month time windows (e.g. 0-6 months, >6-12 months, >12-18 months, >18-24 months).
Time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 33506766Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GRAIL Study Director study director
GRAIL, Inc.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Cancer, run by GRAIL, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the performance of the pre-specified GRAIL Test to detect invasive cancers (including hematologic malignancies). (time frame: From date of first blood draw until first documented invasive cancer diagnosis, assessed up to 30 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.