A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC

NCT06267690 | Completed

• 1 other identifier: SYSUFAH2021025
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 1

Brief Summary

Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• fibrosis

  percentage

  after the surgery

Study Arms (2)

high fibrosis group

No intervention had been adminstered during treatment of patients.

Procedure: surgery

low fibrosis group

No intervention had been adminstered during treatment of patients.

Procedure: surgery

Interventions

surgery PROCEDURE

Patients with suspected pancreatic cancer who underwent contrast-enhanced CT and pathological examinations after the surgery.

high fibrosis group; low fibrosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected pancreatic tumors who underwent contrast-enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study.

You may not qualify if:

• (a) pathologically diagnosed PDAC by resection; (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) no history of previous treatment such as resection, chemotherapy, or radiotherapy. The patients were excluded as follows: (a) unavailable pathological sections for evaluating the fibrosis; (b) incomplete clinical records; (c) missing CT images or poor CT image quality; (d) coincidence of other malignant tumors

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Shi Siya

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue specimens were fixed in 10% formalin and processed routinely. The tumor area with the richest fibrosis was selected, sectioned at a thickness of 4 μm, and stained using Masson's trichrome stain. The collagen fraction (CF), a quantitative substitute for fibrosis, was analyzed using ImageJ software.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Shi-Ting Feng, MD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical doctor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: January 13, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)