Pancreatic CancerNCT04560270
CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer
A study testing Blood samples in people with Pancreatic Cancer and Circulating Tumor DNA, run by Poitiers University Hospital.
Trial summary
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Circulating Tumor DNA, KRAS Mutation-Related Tumors
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2016to 15 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proven pancreatic adenocarcinoma (histology or cytology)
- Metastatic or locally advanced unresectable
- With thoraco-abdomino-pelvic scanner less than a month old
- Chemotherapy treatment regardless of the protocol
- Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
- Informed consent signed by the patient after clear and fair information about the study
Who cannot join
- Linguistic or psychological refusal or inability to understand and / or sign the informed consent
- History of cancer in the 5 years preceding inclusion
- Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
- Immediately resectable tumor
About this study
Official title: KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem.
The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
Read the detailed description
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012).
Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it.
A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations.
Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma.
The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
- Being tested
- Blood samples
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Blood samples to determine ctDNA levels during chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Only arm | Experimental | Blood samples to analyze ctDNA Receives: Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the ctDNA level to the response to chemotherapy
Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan
Measured: 3 months
Secondary outcomes (2)
Overall survival
Correlation between variation of ctDNA and overall survival
Measured: 6 months after last patients inclusion
Progression free survival
Correlation between variation of ctDNA and progression free survival
Measured: 6 months after last patients inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start25 Apr 2016
- Primary completion28 Jun 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560270
- Sponsor's protocol ID
- KRASCIPANC
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evrard C, Ingrand P, Rochelle T, Martel M, Tachon G, Flores N, Randrian V, Ferru A, Haineaux PA, Goujon JM, Karayan-Tapon L, Tougeron D. Circulating tumor DNA in unresectable pancreatic cancer is a strong predictor of first-line treatment efficacy: The KRASCIPANC prospective study. Dig Liver Dis. 2023 Nov;55(11):1562-1572. doi: 10.1016/j.dld.2023.03.011. Epub 2023 Jun 10.
PubMed 37308396
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer
- ClinicalTrials.gov ID
- NCT04560270
- Acronym / sponsor ID
- KRASCIPANC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 23 Sep 2020 (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.
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem.
The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
Detailed description
With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012).
Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it.
A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations.
Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma.
The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only arm | Experimental | Diagnostic Test: Blood samplesBlood samples to analyze ctDNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Proven pancreatic adenocarcinoma (histology or cytology)
- Metastatic or locally advanced unresectable
- With thoraco-abdomino-pelvic scanner less than a month old
- Chemotherapy treatment regardless of the protocol
- Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
Key exclusion criteria (4 listed)
- Linguistic or psychological refusal or inability to understand and / or sign the informed consent
- History of cancer in the 5 years preceding inclusion
- Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
- Immediately resectable tumor
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 |
|---|---|---|
| Blood samplesBlood samples to determine ctDNA levels during chemotherapy | Diagnostic test | Only arm |
Primary outcome
Correlation of the ctDNA level to the response to chemotherapy
Time frame: 3 months
Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan
2 secondary outcomes
Overall survival
Time frame: 6 months after last patients inclusion
Progression free survival
Time frame: 6 months after last patients inclusion
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 23 Sep 2020.
- Derived from this study: PubMed 37308396Evrard C, Ingrand P, Rochelle T, Martel M, Tachon G, Flores N, Randrian V, Ferru A, Haineaux PA, Goujon JM, Karayan-Tapon L, Tougeron D. Circulating tumor DNA in unresectable pancreatic cancer is a strong predictor of first-line treatment efficacy: The KRASCIPANC prospective study. Dig Liver Dis. 2023 Nov;55(11):1562-1572. doi: 10.1016/j.dld.2023.03.011. Epub 2023 Jun 10.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Pancreatic Cancer and Circulating Tumor DNA, run by Poitiers University Hospital.
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 6 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation of the ctDNA level to the response to chemotherapy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560270, which also lists 1 linked publication.
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 23 Sep 2020.