Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer

NCT04110769 | Unknown

• 1 other identifier: NACTMarker-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify and apply biomarkers that can provide better information than previous imaging and blood tests when evaluating the response after neoadjuvant chemotherapy in pancreatic cancer patients who require neoadjuvant therapy before surgery.

Conditions

Genetic Change; Chemotherapy Effect; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The rate of genetic mutation

  Discovery of genetic mutation in response to neoadjuvant chemotherapy

  before neoadjuvant chemotherapy

Secondary Outcomes (1)

• oncologic outcome

  3 - 5 years after surgery

Study Arms (2)

Responders

EXPERIMENTAL

The investigator will administer neoadjuvant chemotherapy After neoadjuvant chemotherapy, multidisciplinary team will decide to surgery or continuing chemotherapy based on following imaging studies and tumor markers. The patients who undergo surgery after neoadjuvant chemotherapy will be included responders.

Diagnostic Test: next generation sequencing

Non-responders

ACTIVE COMPARATOR

The patients who show cancer progression even after neoadjuvant chemotherapy will be classify with non-responder. And the investigator will change palliative chemotherapy.

Diagnostic Test: next generation sequencing; Diagnostic Test: following next generation sequencing

Interventions

next generation sequencing DIAGNOSTIC_TEST

the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.

Non-responders; Responders

following next generation sequencing DIAGNOSTIC_TEST

The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.

Non-responders

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients who are going to administer neoadjuvant chemotherapy for borderline resectable or locally advanced pancreatic cancer
• Performance: 0-2
• No distant metastasis
• Patients who consented to and signed the consent

You may not qualify if:

• Distant metastasis
• Patients included in other clinical studies that may affect this study
• Patients who cannot follow the directions of the researcher
• Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
• Pelvic tumor, benign tumor, malignant tumor in other organs
• Patients who received prior chemotherapy

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Song-Choel Kim, MD.PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song-Choel Kim, MD.PhD

CONTACT

82-2-3010-3933; drksc@amc.seoul.kr

Woohyung Lee, MD

CONTACT

82-2-3010-3933; ywhnet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: October 1, 2019
• Study Start: July 17, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

KR (1)