Predictive Value Of Analysing Tissue From Patients With Metastatic Pancreatic Cancer For Drug Sensitivity

Study Overview

Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity

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.

N/A

Metastatic Pancreatic Cancer

DIAGNOSTIC_TEST: Inditreat
DRUG: Experimental drug

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-01-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-04-28
First Submitted that Met QC Criteria 2019-01-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-05-01
First Posted (ACTUAL) 2019-01-30	Results First Posted N/A	Last Verified 2023-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Standard treatment Standard first line treatment	DIAGNOSTIC_TEST: Inditreat Tumoroid formation and drug sensitivity analysis DRUG: Experimental drug Second line treatment based on drug sensitivity analysis

Participant Group/Arm

Intervention/Treatment

: Standard treatment

Standard first line treatment

DIAGNOSTIC_TEST: Inditreat

Tumoroid formation and drug sensitivity analysis

DRUG: Experimental drug

Second line treatment based on drug sensitivity analysis

Primary Outcome Measures	Measure Description	Time Frame
Predictive value of in-vitro testing	Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy	2 months

Secondary Outcome Measures	Measure Description	Time Frame
Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria)		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)		Every 2 months up to 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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,
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Lars Henrik Jensen, MD, PhD, Vejle Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record