Clinical trial NCT06147154: Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients
Official title: Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To investigate the microbial and metabolic differences between PHC and PBTC and explore the etiology and development of PHC and PBTC by 16S rRNA amplicon sequencing and untargeted metabolome analysis.

Brief summary: Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC.

However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.


Eligibility criteria: Inclusion Criteria:

1. Participants aged above 18 years.
2. Patients who signed informed consent.
3. PDAC patients diagnosed via postoperative pathology.

Exclusion Criteria:

1. Comorbidity with other cancers.
2. Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.
3. Use of antibiotics, probiotics or prebiotics in the previous month.

Primary outcomes:
measure: the abundance of changed microorganisms of PHC and PBTC
timeFrame: 2023-11-20 to 2023-12-20
measure: the abundance of changed metabolites of PHC and PBTC
timeFrame: 2023-11-20 to 2023-12-20
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: