CancerNCT04241796
Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
A study testing Multi-Cancer Early Detection Test in people with Cancer, run by GRAIL, Inc. at 11 sites in United States.
Trial summary
PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Multi-Cancer Early Detection Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,662 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Dec 2019to 5 Jan 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort A: Elevated Risk Group (70% of cohort):
- Age: Participant must be 50 years of age or older at the time of signing the Informed Consent Form (ICF).
- Participants must meet at least one of the criteria below:
- History of smoking at least 100 cigarettes in his or her lifetime
- Documented genetic cancer predisposition, hereditary cancer syndrome, or meeting criteria for germline testing based on current NCCN guidelines
- Personal history of invasive or hematologic malignancy, with definitive treatment completed greater than 3 years prior to enrollment. Adjuvant hormone therapy for cancer is permissible (ie may be ongoing within 3 years or at the time of enrollment).
Show all 10Show fewer
- Cohort B: Non-Elevated Risk Group (30% of cohort):
- Age: Participant must be 50 years of age or older, at the time of signing the Informed Consent Form (ICF).
- None of the conditions described in Cohort A, criteria 2a-c
- For all participants, capable of giving signed and legally effective informed consent
Who cannot join
- Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
- Personal history of invasive or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
- Definitive treatment for invasive or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer is not an exclusion criterion.
- Individuals who will not be able to comply with the protocol procedures.
- Individuals who are not current patients at a participating center.
- Previous or current participation in another GRAIL-sponsored study.
- Previous or current employees or contractors of GRAIL.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texas Oncology, PA (West TXO)
Amarillo, Texas, 79106
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic
Cleveland, Ohio, 44195
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Woodlands Medical Specialists, PA
Pensacola, Florida, 32503
Oregon Health & Science University
Portland, Oregon, 97201
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Sutter Health
Roseville, California, 95661
Intermountain Healthcare Research
St. George, Utah, 84790
Northwest Cancer Specialists, P.C. dba Compass Oncology
Vancouver, Washington, 98684
About this study
Official title: The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. In cases with a "signal detected" test result (with a predicted or indeterminate tissue of origin (TOO)), the diagnostic work-up will not be dictated by the protocol, but will instead be coordinated by the ordering and treating medical team at the enrolling sites based on the participant's clinical condition, recommendations by each institution's clinical practices, and in consultation with the study investigator and interdisciplinary care team, as necessary. Additionally, proposed clinical care pathways, developed based on a review of guidelines from the National Comprehensive Cancer Network (NCCN), American College of Radiology (ACR) and other professional organizations, should be referenced by the medical team to determine the diagnostic work-up. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Performance of multi-cancer early detection test will be evaluated. Additionally, participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. Participants will be followed for approximately 12 months from the time of enrollment. Cancer status will also be assessed at the 12 month time point.
- Conditions
- Cancer
- Being tested
- Multi-Cancer Early Detection Test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Cancer Early Detection TestDevice
Blood collection and multi-cancer early detection testing with return of results.
| Study group | Role | What they receive |
|---|---|---|
| Elevated Risk and Non-Elevated Risk Groups | Experimental | Two cohorts:
1. Elevated risk group (approximately 70% of the total enrollment) on the basis of history of smoking, documented genetic cancer predisposition, or personal history of invasive or hematologic malignancy.
2. Non-elevated risk group (approximately 30% of the total enrollment) with none of the conditions listed in the Elevated Risk Group. Receives: Device: Multi-Cancer Early Detection Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per participant count of the number and types of diagnostic tests required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Measured: Until diagnostic resolution or 12 months, whichever occurs first
Per participant time required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Measured: Until diagnostic resolution or 12 months, whichever occurs first
Secondary outcomes (8)
Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" multi-cancer early detection test result.
Measured: Up to 12 months
Negative Predictive Value defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" results and completed EOS assessment.
Measured: Up to 12 months
Specificity defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis and completed end of study (EOS) assessment.
Measured: Up to 12 months
Tissue of origin (TOO) accuracy defined as the proportion of correct TOO predictions in participants with determinate TOO returned by the multi-cancer early detection test and cancer diagnosis.
Measured: Up to 12 months
Perceptions of the multi-cancer early detection test result assessed by Adapted Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA). Higher scores represent worse outcomes from 0-95.
Measured: Up to 12 months
Changes in health-related quality of life following the multi-cancer early detection test assessed by Short Form Health Survey (SF-12v2).
The SF-12v2 is a measure of health related quality of life. Higher values represent better health e.g. Physical Component Summary (PCS) range from 4.62 to 76.36 and Mental Component Summary (MCS) range from 1.32 to 79.48.
Measured: Up to 12 months
Changes in anxiety following the multi-cancer early detection test result: Patient-reported Outcome Measurement Information System (PROMIS) Anxiety.
Assessed by Patient-reported Outcome Measurement Information System (PROMIS) Anxiety. Range in score from 4 to 20 with higher scores indicate greater severity of anxiety.
Measured: Up to 12 months
Satisfaction with the multi-cancer early detection test: scores
Range in score from 0-100 with higher scores indicating higher satisfaction.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start12 Dec 2019
- Primary completion1 Dec 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,662 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRAIL, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241796
- Sponsor's protocol ID
- GRAIL-007
- Status last verified
- Oct 2022
- First submitted
- 2 Jan 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nadauld L, McDonnell CH 3rd, Dilaveri CA, Klein EA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Schrag D, Patrick DL. Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre, cohort study. Lancet Oncol. 2025 Feb;26(2):165-174. doi: 10.1016/S1470-2045(24)00645-4. Epub 2025 Jan 13.
PubMed 39818231Mahal BA, Margolis M, Hubbell E, Chen C, Venstrom JM, Abran J, Kartlitz JJ, Wyatt AW, Klein EA. A Targeted Methylation-Based Multicancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer While Minimizing Overdiagnosis of Indolent Disease. JCO Precis Oncol. 2024 Aug;8:e2400269. doi: 10.1200/PO.24.00269.
PubMed 39208374Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.
PubMed 37805216
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
- ClinicalTrials.gov ID
- NCT04241796
- Acronym / sponsor ID
- GRAIL-007
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,662 participants (actual)
- Lead sponsor
- GRAIL, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 27 Jan 2020 (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.
PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. In cases with a "signal detected" test result (with a predicted or indeterminate tissue of origin (TOO)), the diagnostic work-up will not be dictated by the protocol, but will instead be coordinated by the ordering and treating medical team at the enrolling sites based on the participant's clinical condition, recommendations by each institution's clinical practices, and in consultation with the study investigator and interdisciplinary care team, as necessary. Additionally, proposed clinical care pathways, developed based on a review of guidelines from the National Comprehensive Cancer Network (NCCN), American College of Radiology (ACR) and other professional organizations, should be referenced by the medical team to determine the diagnostic work-up. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Performance of multi-cancer early detection test will be evaluated. Additionally, participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. Participants will be followed for approximately 12 months from the time of enrollment. Cancer status will also be assessed at the 12 month time point.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elevated Risk and Non-Elevated Risk Groups | Experimental | Device: Multi-Cancer Early Detection TestTwo cohorts: 1. Elevated risk group (approximately 70% of the total enrollment) on the basis of history of smoking, documented genetic cancer predisposition, or personal history of invasive or hematologic malignancy. 2. Non-elevated risk group (approximately 30% of the total enrollment) with none of the conditions listed in the Elevated Risk Group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: Participant must be 50 years of age or older at the time of signing the Informed Consent Form (ICF).
- Participants must meet at least one of the criteria below:
- History of smoking at least 100 cigarettes in his or her lifetime
- Documented genetic cancer predisposition, hereditary cancer syndrome, or meeting criteria for germline testing based on current NCCN guidelines
- Personal history of invasive or hematologic malignancy, with definitive treatment completed greater than 3 years prior to enrollment. Adjuvant hormone therapy for cancer is permissible (ie may be ongoing within 3 years or at the time of enrollment).
Key exclusion criteria (7 listed)
- Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
- Personal history of invasive or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
- Definitive treatment for invasive or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer is not an exclusion criterion.
- Individuals who will not be able to comply with the protocol procedures.
- Individuals who are not current patients at a participating center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Cancer Early Detection TestBlood collection and multi-cancer early detection testing with return of results. | Device | Elevated Risk and Non-Elevated Risk Groups |
Primary outcome
Per participant count of the number and types of diagnostic tests required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Time frame: Until diagnostic resolution or 12 months, whichever occurs first
Per participant time required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Time frame: Until diagnostic resolution or 12 months, whichever occurs first
8 secondary outcomes
Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" multi-cancer early detection test result.
Time frame: Up to 12 months
Negative Predictive Value defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" results and completed EOS assessment.
Time frame: Up to 12 months
Specificity defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis and completed end of study (EOS) assessment.
Time frame: Up to 12 months
Tissue of origin (TOO) accuracy defined as the proportion of correct TOO predictions in participants with determinate TOO returned by the multi-cancer early detection test and cancer diagnosis.
Time frame: Up to 12 months
Perceptions of the multi-cancer early detection test result assessed by Adapted Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA). Higher scores represent worse outcomes from 0-95.
Time frame: Up to 12 months
Changes in health-related quality of life following the multi-cancer early detection test assessed by Short Form Health Survey (SF-12v2).
Time frame: Up to 12 months
Changes in anxiety following the multi-cancer early detection test result: Patient-reported Outcome Measurement Information System (PROMIS) Anxiety.
Time frame: Up to 12 months
Satisfaction with the multi-cancer early detection test: scores
Time frame: Up to 12 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 25 Oct 2022.
- Derived from this study: PubMed 39818231Nadauld L, McDonnell CH 3rd, Dilaveri CA, Klein EA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Schrag D, Patrick DL. Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre, cohort study. Lancet Oncol. 2025 Feb;26(2):165-174. doi: 10.1016/S1470-2045(24)00645-4. Epub 2025 Jan 13.
- Derived from this study: PubMed 39208374Mahal BA, Margolis M, Hubbell E, Chen C, Venstrom JM, Abran J, Kartlitz JJ, Wyatt AW, Klein EA. A Targeted Methylation-Based Multicancer Early Detection Blood Test Preferentially Detects High-Grade Prostate Cancer While Minimizing Overdiagnosis of Indolent Disease. JCO Precis Oncol. 2024 Aug;8:e2400269. doi: 10.1200/PO.24.00269.
- Derived from this study: PubMed 37805216Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Cancer Early Detection Test in people with Cancer, run by GRAIL, Inc. at 11 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 10 inclusion and 7 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Per participant count of the number and types of diagnostic tests required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result. (time frame: Until diagnostic resolution or 12 months, whichever occurs first). 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 NCT04241796, which also lists 3 linked publications.
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 25 Oct 2022.