Non-small Cell Lung CancerNCT04638751
ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
An observational study of Non-small Cell Lung Cancer and Colorectal Cancer, run by Persephone Biosciences at 10 sites in United States.
Trial summary
ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer
- What is being tested?
- Immunotherapy, Chemotherapy and CRC surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2028
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is anticipated that up to 5000 subjects will be enrolled in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent.
Who may be able to join
- Men or women who are ≥ 18 years old with stage III or stage IV non-small cell lung cancer (NSCLC), colorectal cancer, triple-negative breast cancer, or pancreatic cancer treated by a particular cancer treatment for the first time, OR healthy subjects undergoing a standard of care colonoscopy
- Subjects able to provide written informed consent
Who cannot join
- Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
- Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
- Women who are pregnant or who plan on becoming pregnant
- Women who are nursing
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
Kroger Health, The Little Clinic
Cincinnati, Ohio, 45202
Southwest Family Medicine Associates
Dallas, Texas, 75235
Biopharma Informatic
Houston, Texas, 77089
L&A Morales Healthcare, Inc
Miami, Florida, 33142
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Mid-Hudson Medical Research
New Windsor, New York, 12553
Knowledge Research Center
Orange, California, 92866
SDG Clinical Research, Inc
San Diego, California, 92103
Persephone Biosciences, Inc.
San Diego, California, 92121
About this study
Official title: ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut Microbiomes on Response to Treatment
ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment.
Currently enrolling the CRC, high risk, and low risk cohorts.
Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years.
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer
- Being tested
- Immunotherapy, Chemotherapy, CRC surgical resection, Colonoscopy
- Keywords
- microbiome, immunotherapy, checkpoint inhibitor, cancer, colonoscopy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Checkpoint inhibitor
ChemotherapyDrug
Any form of chemotherapy
CRC surgical resectionProcedure or surgery
Surgical resection to remove colorectal cancer
ColonoscopyProcedure or surgery
Standard-of-care colonoscopy for CRC screening
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | Stage 3 or stage 4 non-small cell lung cancer patients, being administered checkpoint inhibitor therapy for the first time. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. Receives: Drug: Immunotherapy | |
| Triple-negative breast cancer | Stage 3 or stage 4 metastatic triple-negative breast cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. Receives: Drug: Chemotherapy | |
| Colorectal cancer | Stage 3 or stage 4 colorectal cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. Receives: Drug: Immunotherapy; Drug: Chemotherapy; Procedure: CRC surgical resection | |
| Pancreatic cancer | Stage 3 or stage 4 pancreatic cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. Receives: Drug: Immunotherapy; Drug: Chemotherapy | |
| High risk for colorectal cancer | Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening considered at high risk for CRC due to either 1) one or more first degree relatives with a history of CRC, or 2) a personal history of colorectal cancer, advanced adenoma as defined by USMSTF guidelines on colorectal cancer, or 3 or more non-advanced adenomas in a single screening or surveillance encounter (synchronous). Receives: Procedure: Colonoscopy | |
| Low risk for colorectal cancer | Subjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening, who are not considered high risk for CRC based on family history or prior colonoscopy findings. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether the microbiome composition can predict progression-free survival
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment
Measured: 6-12 months
Determine whether the microbiome composition can predict risk for colorectal cancer
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome. High and low risk subjects will be followed for 8 years to determine if any get CRC.
Measured: 2-8 years
Secondary outcomes (3)
Identify correlations between microbiome composition and immune markers
CyTOF and cytokine analysis will be performed on the blood samples to characterize the patient's immune phenotype
Measured: 6-12 months
Determine whether the microbiome composition can predict overall survival
Survival and tumor progression will be monitored for an extended time beyond sample collection
Measured: 6-24 months
Build a library of samples and data for future research
Samples will be stored and data saved in a HIPAA-compliant database. Samples will be linked to patient metadata.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jul 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Currently no funding to continue study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Persephone Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638751
- Sponsor's protocol ID
- PB-2020-01
- Status last verified
- Sep 2026
- First submitted
- 16 Nov 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut Microbiomes on Response to Treatment
- ClinicalTrials.gov ID
- NCT04638751
- Acronym / sponsor ID
- PB-2020-01
- Conditions
- Non-small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Pancreas Cancer
- Keywords
- microbiome, immunotherapy, checkpoint inhibitor, cancer, colonoscopy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Currently no funding to continue study.
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Persephone BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 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.
ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment.
Currently enrolling the CRC, high risk, and low risk cohorts.
Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | Drug: ImmunotherapyStage 3 or stage 4 non-small cell lung cancer patients, being administered checkpoint inhibitor therapy for the first time. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. |
| Triple-negative breast cancer | – | Drug: ChemotherapyStage 3 or stage 4 metastatic triple-negative breast cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. |
| Colorectal cancer | – | Drug: Immunotherapy, Drug: Chemotherapy, Procedure: CRC surgical resectionStage 3 or stage 4 colorectal cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. |
| Pancreatic cancer | – | Drug: Immunotherapy, Drug: ChemotherapyStage 3 or stage 4 pancreatic cancer patients, being administered any type of treatment that the patient has not experienced before. Dosage form, dosage, frequency and duration will be either standard of care and accessed via normal commissioning arrangements, or will be part of an ethics-approved clinical trial, where co-enrollment into an observational study is permitted. |
| High risk for colorectal cancer | – | Procedure: ColonoscopySubjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening considered at high risk for CRC due to either 1) one or more first degree relatives with a history of CRC, or 2) a personal history of colorectal cancer, advanced adenoma as defined by USMSTF guidelines on colorectal cancer, or 3 or more non-advanced adenomas in a single screening or surveillance encounter (synchronous). |
| Low risk for colorectal cancer | – | Procedure: ColonoscopySubjects undergoing a standard-of-care colonoscopy for colorectal cancer (CRC) screening, who are not considered high risk for CRC based on family history or prior colonoscopy findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is anticipated that up to 5000 subjects will be enrolled in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent.
Key inclusion criteria (2 listed)
- Men or women who are ≥ 18 years old with stage III or stage IV non-small cell lung cancer (NSCLC), colorectal cancer, triple-negative breast cancer, or pancreatic cancer treated by a particular cancer treatment for the first time, OR healthy subjects undergoing a standard of care colonoscopy
- Subjects able to provide written informed consent
Key exclusion criteria (4 listed)
- Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
- Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
- Women who are pregnant or who plan on becoming pregnant
- Women who are nursing
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 |
|---|---|---|
| ImmunotherapyCheckpoint inhibitor | Drug | Colorectal cancer, NSCLC, Pancreatic cancer |
| ChemotherapyAny form of chemotherapy | Drug | Colorectal cancer, Pancreatic cancer, Triple-negative breast cancer |
| CRC surgical resectionSurgical resection to remove colorectal cancer | Procedure or surgery | Colorectal cancer |
| ColonoscopyStandard-of-care colonoscopy for CRC screening | Procedure or surgery | High risk for colorectal cancer, Low risk for colorectal cancer |
Primary outcome
Determine whether the microbiome composition can predict progression-free survival
Time frame: 6-12 months
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome, and whether there is any correlation with response to treatment
Determine whether the microbiome composition can predict risk for colorectal cancer
Time frame: 2-8 years
Whole genome sequencing and metabolomics will be used to characterize the patient's microbiome. High and low risk subjects will be followed for 8 years to determine if any get CRC.
3 secondary outcomes
Identify correlations between microbiome composition and immune markers
Time frame: 6-12 months
Determine whether the microbiome composition can predict overall survival
Time frame: 6-24 months
Build a library of samples and data for future research
Time frame: 6-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Colorectal Cancer, run by Persephone Biosciences at 10 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 4 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: paused, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
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?
Determine whether the microbiome composition can predict progression-free survival (time frame: 6-12 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?
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 18 Sep 2026.