Genetic ChangeNCT04110769
Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer
A study testing next generation sequencing and following next generation sequencing in people with Genetic Change and Chemotherapy Effect, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Genetic Change, Chemotherapy Effect, Pancreatic Cancer
- What is being tested?
- next generation sequencing and following next generation sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan medical center
Seoul, 05505
Woohyung Lee, 230103933, ywhnet@gmail.com
About this study
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.
Read the detailed description
BACKGROUND
- Pancreatic cancer is a rare cancer of the digestive system, but it is known to have a poor prognosis with a very poor survival rate. Five-year survival rate of all patients with pancreatic cancer is less than 6%, and only 10-20% of patients are eligible for surgery at the time of diagnosis.
- Postoperative complications of pancreatic cancer are reported in 30-50% of cases, and only 50% of patients undergoing postoperative chemotherapy at the appropriate time after surgery are reported. As a result of these concerns, the study of neoadjuvant chemotherapy (NACT) was begun. Recently, several clinical studies of chemotherapy have been performed. Cancer (BRPC), locally advanced pancreatic cancer (LAPC) patients who have had difficult surgical resection, are turning to treatment by combining surgical treatment after NACT.
- Although standard treatments for advanced chemotherapy have yet to be established through many clinical studies, the most commonly used regimens are FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), gemcitabine and nab-paclitaxel. The response rate after prior chemotherapy is known as 30-50%, and the response of patients undergoing surgery after prior chemotherapy was compared with the serum markers before and after chemotherapy through CA19-9, PET-CT, and CT. The response could be estimated by the reduction, the size change in the imaging test, or the decrease in SUVmax. However, there are only a few studies on genetic and molecular studies of which patients will respond. Under these circumstances, this study on the discovery of biomarkers for the response of advanced chemotherapy in patients with pancreatic cancer may provide guidelines for the application of advanced chemotherapy and the selection of appropriate drugs, as well as clues for future research.
Primary endpoint:
-Discovery of genetic mutation in response to NACT
METHODOLOGY Recruitment and sample collection of patients undergoing NACT Identifying pancreatic cancer specific candidate genes in response to NACT
EXPECTED RESEARCH RESULTS
- Predictable genes and biomarkers of responsiveness for NACT can be identified.
- It is possible to understand the progress of pancreatic cancer widely
- The development of biomarkers that can predict the response of NACT
- In patients with BRPC or LAPC who need NACT, appropriate screening will be possible.
- Conditions
- Genetic Change, Chemotherapy Effect, Pancreatic Cancer
- Being tested
- next generation sequencing, following next generation sequencing
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next generation sequencingDiagnostic test
the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.
following next generation sequencingDiagnostic test
The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: next generation sequencing; Diagnostic Test: following next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of genetic mutation
Discovery of genetic mutation in response to neoadjuvant chemotherapy
Measured: before neoadjuvant chemotherapy
Secondary outcomes (1)
oncologic outcome
overall survival and recurrence free survival
Measured: 3 - 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start17 Jul 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic ChangeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song-Choel Kim, MD.PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110769
- Sponsor's protocol ID
- NACTMarker-01
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarker for the Evaluation of Response After Neoadjuvant Therapy in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04110769
- Acronym / sponsor ID
- NACTMarker-01
- Conditions
- Genetic Change, Chemotherapy Effect, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND
- Pancreatic cancer is a rare cancer of the digestive system, but it is known to have a poor prognosis with a very poor survival rate. Five-year survival rate of all patients with pancreatic cancer is less than 6%, and only 10-20% of patients are eligible for surgery at the time of diagnosis.
- Postoperative complications of pancreatic cancer are reported in 30-50% of cases, and only 50% of patients undergoing postoperative chemotherapy at the appropriate time after surgery are reported. As a result of these concerns, the study of neoadjuvant chemotherapy (NACT) was begun. Recently, several clinical studies of chemotherapy have been performed. Cancer (BRPC), locally advanced pancreatic cancer (LAPC) patients who have had difficult surgical resection, are turning to treatment by combining surgical treatment after NACT.
- Although standard treatments for advanced chemotherapy have yet to be established through many clinical studies, the most commonly used regimens are FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin), gemcitabine and nab-paclitaxel. The response rate after prior chemotherapy is known as 30-50%, and the response of patients undergoing surgery after prior chemotherapy was compared with the serum markers before and after chemotherapy through CA19-9, PET-CT, and CT. The response could be estimated by the reduction, the size change in the imaging test, or the decrease in SUVmax. However, there are only a few studies on genetic and molecular studies of which patients will respond. Under these circumstances, this study on the discovery of biomarkers for the response of advanced chemotherapy in patients with pancreatic cancer may provide guidelines for the application of advanced chemotherapy and the selection of appropriate drugs, as well as clues for future research.
Primary endpoint:
-Discovery of genetic mutation in response to NACT
METHODOLOGY Recruitment and sample collection of patients undergoing NACT Identifying pancreatic cancer specific candidate genes in response to NACT
EXPECTED RESEARCH RESULTS
- Predictable genes and biomarkers of responsiveness for NACT can be identified.
- It is possible to understand the progress of pancreatic cancer widely
- The development of biomarkers that can predict the response of NACT
- In patients with BRPC or LAPC who need NACT, appropriate screening will be possible.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders | Experimental | Diagnostic Test: next generation sequencingThe 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. |
| Non-responders | Active comparator | Diagnostic Test: next generation sequencing, Diagnostic Test: following next generation sequencingThe patients who show cancer progression even after neoadjuvant chemotherapy will be classify with non-responder. And the investigator will change palliative chemotherapy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next generation sequencingthe investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination. | Diagnostic test | Non-responders, Responders |
| following next generation sequencingThe patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders. | Diagnostic test | Non-responders |
Primary outcome
The rate of genetic mutation
Time frame: before neoadjuvant chemotherapy
Discovery of genetic mutation in response to neoadjuvant chemotherapy
1 secondary outcome
oncologic outcome
Time frame: 3 - 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song-Choel Kim, MD.PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing next generation sequencing and following next generation sequencing in people with Genetic Change and Chemotherapy Effect, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song-Choel Kim, MD.PhD (82-2-3010-3933, drksc@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of genetic mutation (time frame: before neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.