Pancreatic CancerNCT06461598
Signature for Precise Chemosensitivity Prediction in PDAC
An observational study of Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Chemotherapy
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 May 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients with incident, primary, microscopically-confirmed nonmetastatic PDAC who underwent resection were initially enrolled.
Who may be able to join
- ECOG performance status score of 0-1 before resection
- complete clinicopathologic and follow-up data
- availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components
Who cannot join
- any previous history of cancer
- any anticancer therapy prior to resection or adjuvant radiotherapy
- metastatic cases
- major postsurgical complications with Clavien-Dindo Grade ≥2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma
Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.
- Conditions
- Pancreatic Cancer
- Being tested
- Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
All adjuvant chemotherapy for nonmetastatic PDAC was gemcitabine-based (Cycle >= 1).
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Not described Receives: Drug: Chemotherapy | |
| Validation cohort | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time between resection and death of any cause
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2018
- Primary completion16 Mar 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lei huang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461598
- Sponsor's protocol ID
- ChemoResist-01
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06461598
- Acronym / sponsor ID
- ChemoResist-01
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Jun 2024 (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.
Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Drug: Chemotherapy |
| Validation cohort | – | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with incident, primary, microscopically-confirmed nonmetastatic PDAC who underwent resection were initially enrolled.
Key inclusion criteria (3 listed)
- ECOG performance status score of 0-1 before resection
- complete clinicopathologic and follow-up data
- availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components
Key exclusion criteria (4 listed)
- any previous history of cancer
- any anticancer therapy prior to resection or adjuvant radiotherapy
- metastatic cases
- major postsurgical complications with Clavien-Dindo Grade ≥2
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 |
|---|---|---|
| ChemotherapyAll adjuvant chemotherapy for nonmetastatic PDAC was gemcitabine-based (Cycle >= 1). | Drug | Training cohort, Validation cohort |
Primary outcome
Overall survival
Time frame: 3-year
Time between resection and death of any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jun 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3-year). 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 17 Jun 2024.