NCT05873231

Brief Summary

The role of the gut microbiome in the development of side effects of anti cancer treatment will be assessed in this longitudinal cohort study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
80mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Apr 2021Dec 2032

Study Start

First participant enrolled

April 28, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

9.6 years

First QC Date

May 15, 2023

Last Update Submit

November 24, 2025

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • gut microbiome composition

    16s sequencing

    4-12 weeks

Secondary Outcomes (6)

  • stool zonulin

    4-12 weeks

  • stool calprotectin

    4-12 weeks

  • serum lipopolysaccharide binding protein

    4-12 weeks

  • serum soluble cluster of differentiation (CD)14

    4-12 weeks

  • Bristol stool scale (BSS)

    4-12 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients receiving systemic anti cancer therapy

You may qualify if:

  • years or older
  • Start of a systemic anti-cancer therapy
  • Informed consent

You may not qualify if:

  • Pre-existing diarrhoea
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, urine, stool

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

April 28, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2032

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Sequencing data will be shared in an open repository

Time Frame
upon publication of the results
Access Criteria
open access

Locations

AU(1)