Associations of intestinal microbiota signatures with the efficacy and toxicity of chemotherapy in patients with advanced pancreatic cancer

Associations of intestinal microbiota signatures with the efficacy and toxicity of chemotherapy in patients with advanced pancreatic cancer - PaCTx

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022201

Enrollment

200

Registered

2020-06-18

Start date

2020-05-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C25.9

Interventions

Group 1: A cohort of patients with locally advanced or metastatic PDAC or recurrence after PDAC resection who will receive palliative chemotherapy following medical indication will be recruited at the

additional recruitment-centers are the Tumor Center of the University Hospital Cologne, the West German Tumor Center in Essen and the Clinical Center Darmstadt. Patients will be informed about the pos

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with locally advanced or metastatic PDAC or recurrence after primary PDAC resection who receive palliative chemotherapy based on medical indication. - Persons who have understood the informed consent and signed the written consent form.

Exclusion criteria

Exclusion criteria: - Refusal by the patient - Age < 18 years - Lack of ability to consent - Pancreas resection with (neo)adjuvant chemotherapy - Previous treatment of other malignant cancers

Design outcomes

Primary

Measure	Time frame
Alpha diversity as a parameter for bacterial diversity in the fecal microbiota, analyzed at the time of initiation of chemotherapy treatment in newly diagnosed, locally advanced or metastatic PDAC, and the association with survival (follow-up up to max. 36 months).	—

Secondary

Measure	Time frame
- To study the composition and beta diversity of oral and fecal microbiota at the time of PDAC diagnosis, and and changes therein during and following palliative chemotherapy. - Investigation of the bacterial metagenome in oral and fecal microbiota samples to determine microbial metabolic pathways at the time of PDAC diagnosis and during palliative chemotherapy. - Collection of clinical data on the efficacy of chemotherapy (response, relapse), toxicity of chemotherapy (e.g. mucositis, diarrhoea, polyneuropathy, bone marrow toxicity), occurrence of infections (e.g. sepsis, cholangitis), death.	—

Measure

Time frame

- To study the composition and beta diversity of oral and fecal microbiota at the time of PDAC diagnosis, and and changes therein during and following palliative chemotherapy. - Investigation of the bacterial metagenome in oral and fecal microbiota samples to determine microbial metabolic pathways at the time of PDAC diagnosis and during palliative chemotherapy. - Collection of clinical data on the efficacy of chemotherapy (response, relapse), toxicity of chemotherapy (e.g. mucositis, diarrhoea, polyneuropathy, bone marrow toxicity), occurrence of infections (e.g. sepsis, cholangitis), death.

—

Countries

Germany

Contacts

Public ContactChristoph Stein-Thoeringer

German Cancer Research Center (DKFZ)

christoph.stein-thoeringer@uni-tuebingen.de+496221424952

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026