We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03821870
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03821870
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : April 27, 2022
Information provided by (Responsible Party):
Vejle Hospital

Brief 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.

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.

Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer Diagnostic Test: Inditreat Drug: Experimental drug

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
Actual Study Start Date : February 25, 2019
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Group/Cohort 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 :
  1. 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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Liver biopsy and blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic pancreatic cancer eligible for chemotherapy

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821870

Layout table for location contacts
Contact: Lars Henrik Jensen, MD, PhD +45 7940 6802 lars.henrik.jensen@rsyd.dk

Layout table for location information
Departmen of Oncology, Vejle Hospital Recruiting
Vejle, Denmark
Contact: Lars H Jensen, MD       lars.henrik.jensen@rsyd.dk   
Sponsors and Collaborators
Vejle Hospital
Layout table for investigator information
Study Chair: Lars Henrik Jensen, MD, PhD Vejle Hospital
Layout table for additonal information
Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT03821870    
Other Study ID Numbers: TIP
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases