Metastatic Pancreatic CancerTIPNCT03821870
Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity
An observational study of Metastatic Pancreatic Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Inditreat and Experimental drug
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2019to 22 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic pancreatic cancer eligible for chemotherapy
Who may be able to join
- Non-resectable pancreatic cancer
- Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis)
- If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas
- Deemed non-resectable at a multidisciplinary conference
- Candidate to standard systemic therapy, defined as one of
- Gemcitabine monotherapy,
Show all 19Show fewer
- Gemcitabine and nab-paclitaxel combination,
- Gemcitabine and capecitabine combination,
- 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
- New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' in the inclusion period.
- Measurable disease according to RECIST 1.1
- ECOG performance status 0-2
- Age at least 18 years
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy
- Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l
- Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value
- Calculated or measured renal glomerular filtration rate at least 30 mL/min
- Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
- Written and orally informed consent
Who cannot join
- Potentially resectable disease
- Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
- Other active malignant disease requiring therapy
- Other systemic anti-cancer therapy (palliative radiotherapy is allowed)
- Pregnant (positive pregnancy test) or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated.
Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Inditreat, Experimental drug
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InditreatDiagnostic test
Tumoroid formation and drug sensitivity analysis
Experimental drugDrug
Second line treatment based on drug sensitivity analysis
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Standard first line treatment Receives: Diagnostic Test: Inditreat; Drug: Experimental drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of in-vitro testing
Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy
Measured: 2 months
Secondary outcomes (2)
Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)
Measured: Every 2 months during treatment up to 180 days
Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)
Measured: Every 2 months up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start25 Feb 2019
- Primary completion31 Dec 2021
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Henrik Jensen, MD, PhD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821870
- Sponsor's protocol ID
- TIP
- Acronym
- TIP
- Status last verified
- Apr 2023
- First submitted
- 9 Jan 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03821870
- Acronym / sponsor ID
- TIP / TIP
- Conditions
- Metastatic Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 30 Jan 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.
It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated.
Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | – | Diagnostic Test: Inditreat, Drug: Experimental drugStandard first line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic pancreatic cancer eligible for chemotherapy
Key inclusion criteria (19 listed)
- Non-resectable pancreatic cancer
- Candidate to standard systemic therapy, defined as one of
- Measurable disease according to RECIST 1.1
- ECOG performance status 0-2
- Age at least 18 years
Key exclusion criteria (5 listed)
- Potentially resectable disease
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 |
|---|---|---|
| InditreatTumoroid formation and drug sensitivity analysis | Diagnostic test | Standard treatment |
| Experimental drugSecond line treatment based on drug sensitivity analysis | Drug | Standard treatment |
Primary outcome
Predictive value of in-vitro testing
Time frame: 2 months
Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy
2 secondary outcomes
Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)
Time frame: Every 2 months during treatment up to 180 days
Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS)
Time frame: Every 2 months up to 12 months
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 1 May 2023.
- 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.
Lars Henrik Jensen, MD, PhD study chair
Vejle Hospital
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 Metastatic Pancreatic Cancer, run by Vejle Hospital at 1 site in Denmark.
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 19 inclusion and 5 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 1 May 2023. 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 Denmark. 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?
Predictive value of in-vitro testing (time frame: 2 months). 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 1 May 2023.