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Gut bacteria may hold clues to why some cancer treatments work better

NCT ID NCT04638751

Knowledge-focused Sponsor: Persephone Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are building a large bank of blood and stool samples from people with advanced lung, breast, colorectal, and pancreatic cancers, plus healthy volunteers. The goal is to learn whether the mix of bacteria in a person's gut can predict how well cancer treatment works and who is at risk for colorectal cancer. Participants give up to five blood and stool samples over two years, and some also provide colon tissue. The study follows health records for up to eight years to track treatment response and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the microbiome turns out to predict treatment response, doctors could one day use a stool test to help choose cancer therapies or adjust gut bacteria to improve outcomes.
What could go wrong
This is an observational study, so it cannot prove that gut bacteria cause better or worse treatment results. Links found here may not hold up in larger or more diverse groups, and any microbiome-based treatment would still need years of separate testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm malignant pancreatic neoplasm neoplasm non-small cell lung carcinoma pancreatic neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Non-small cell lung cancer Pancreas cancer Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70809, United States

  • Biopharma Informatic

    Houston, Texas, 77089, United States

  • Knowledge Research Center

    Orange, California, 92866, United States

  • Kroger Health, The Little Clinic

    Cincinnati, Ohio, 45202, United States

  • L&A Morales Healthcare, Inc

    Miami, Florida, 33142, United States

  • Mid-Hudson Medical Research

    New Windsor, New York, 12553, United States

  • Persephone Biosciences, Inc.

    San Diego, California, 92121, United States

  • SDG Clinical Research, Inc

    San Diego, California, 92103, United States

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235, United States

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

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