Clinical trial NCT04736043: Development of a Prediction Platform for Adjuvant Treatment and Prognosis in Resected Pancreatic Cancer Using Organoid
Official title: Development of a Prediction Platform for Adjuvant Treatment and Prognosis in Pancreatic Cancer Using Ex Vivo Analysis of Organoid Culture
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer Resectable
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A patient who is in need of adjuvant chemotherapy after surgery, having been diagnosed with pancreatic cancer via EUS-FNA and EUS-FNB at Samsung Medical Center

Brief summary: The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as adjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate adjuvant chemotherapy after surgery, thus developing a platform to predict the outcomes of each patient.


Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. Newly discovered pancreatic cancer and not a relapse
3. Diagnosed with pancreatic cancer via EUS-FNA, EUS-FNB before surgery
4. Patients who can undergo surgery for pancreatic cancer
5. Diagnosed with pancreatic cancer from the final tissue pathology diagnosis after surgery
6. who is in need of adjuvant chemotherapy after surgery
7. Able to make decisions for oneself for participation
8. Has obtained voluntary consent in written form (if 70 years of age or older, receive consent from the guardian as well)

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival rate
timeFrame: From date of initiation of adjuvant chemotherapy after surgery until the date of death from any cause, assessed up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
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