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NCT Number: NCT03085888

The STRIVE Study: Development of a Blood Test for Early Detection of Multiple Cancer Types

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.

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Key information

Conditions

Neoplasms Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

None.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    sequencing to characterize cfNA profiles.

  2. 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

Sponsors and collaborators

Lead sponsor

GRAIL, Inc.

Industry

Registry information

Official study title

The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Mar 21, 2017
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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