Evaluation of Tumour Growth and Oncological Treatment in Patients With CRLM Using Zebra Fish Embryo Model

NCT05289076 | Unknown Phase 1

• 1 other identifier: Academic study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In order to improve and individualize cancer treatment, personalized treatment needs to be developed much further. Liver metastasizing colorectal cancer is treated with a combination of oncological and surgical interventions. The selection of chemotherapy is today mainly done according to best guess. Today only a small fraction of oncological treatment may be known to be effective in a person before treatment start, most often it is trial and error. A fast reliable system for looking at response to different treatments in each unique patient is much needed and would, if successful, completely change the way we give oncological treatment today. Patient's tumor tissue will be evaluated with use of zebrafish embryo avatars to evaluate tumour growth and response to different combinations of chemotherapy. If successful interventional studies are planned.

Conditions

Colorectal Cancer Metastatic; Tumour Metastasis; Chemotherapy Effect; Tumor Growth

Outcome Measures

Primary Outcomes (2)

• Successful tumour growth in zebra fish embryos

  % of implanted tumour that grow in zebrafish embryos

  In each embryo within 3 days

• Response evaluation of different combinations of chemotherapy in zebra fish embryos implanted with colorectal liver metastatic tissue

  The relative tumour area between the time of implantation and day 3 in each zebrafish embryo

  In each embryo within 3 days

Study Arms (1)

Colorectal liver metastsis, single arm

EXPERIMENTAL

Tumour tissue from patients operated for colorectal liver metastases. A cubic centimeter of tumour tissue will be processed and implanted in zebra fish embryos. Tissue in zebrafish embryos will treated with different combinations of chemotherapy. Chemocombination of best effect will be offered patients in the third phase of the trial

Drug: Chemotherapy drug

Interventions

Chemotherapy drug DRUG

Different combinations of chemotherapies will be tested in combination with monoclonal antibodies in zebrafish embryos against inplanted patients livermetastatic tissues.

Colorectal liver metastsis, single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed or suspected diagnosis of colorectal liver metastasis Age 18 years or older ECOG 0-2 Patient can understand verbal and written information -

You may not qualify if:

• Age less than 18 years ECOG \>2 Patient is not able to understand the verbal and written information

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Medical Research Council of Southeast Sweden: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Per Sandström

Linköping, Östergötland County, 58185, Sweden

RECRUITING

Related Publications (15)

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MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bärbel Jung, PhD

  University hospital Linkoing

  STUDY DIRECTOR

Central Study Contacts

Per Sandström, Prof

CONTACT

+46734058581; per.sandstrom@liu.se

Bergthor Bjornsson, Prof

CONTACT

+46101033666; bergthor.bjornsson@liu.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 21, 2022
• Study Start: May 17, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

SE (1)