Clinical trial NCT04638751: ARGONAUT: Stool and Blood Sample Bank for Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Colorectal Cancer
Triple Negative Breast Cancer
Pancreas Cancer
Keywords: microbiome
immunotherapy
checkpoint inhibitor
cancer
colonoscopy
Lead sponsor: Persephone Biosciences
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determine whether the microbiome composition can predict progression-free survival
timeFrame: 6-12 months
measure: Determine whether the microbiome composition can predict risk for colorectal cancer
timeFrame: 2-8 years
Secondary outcomes:
measure: Identify correlations between microbiome composition and immune markers
timeFrame: 6-12 months
measure: Determine whether the microbiome composition can predict overall survival
timeFrame: 6-24 months
measure: Build a library of samples and data for future research
timeFrame: 6-24 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: San Diego
country: United States
facility: SDG Clinical Research, Inc
state: California
city: San Diego
country: United States
facility: Persephone Biosciences, Inc.
state: California
city: Miami
country: United States
facility: L&A Morales Healthcare, Inc
state: Florida
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Windsor
country: United States
facility: Mid-Hudson Medical Research
state: New York
city: Cincinnati
country: United States
facility: Kroger Health, The Little Clinic
state: Ohio
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic
state: Texas
Study officials:
References: