Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars

NCT06270017 | Recruiting Phase 1 DMC

• 1 other identifier: 282242
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In order to improve and individualize cancer treatment personalized treatments developed much further. Colon cancer is treated with surgery and thereafter adjuvant oncological treatment. 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. This system would also be possible to use to evaluate new treatments and if successful, implement in the clinical setting. In this project we will implant a part of the patient's tumour tissue into a zebrafish embryo and evaluate tumour growth and frequency of metastatic disease as well as response to given oncological treatment. 2.2 Objective: The objective of this project is to explore the usefulness of zebrafish (Danio Rerio) embryo models to determine tumor biology and treatment response in colon cancer. An overarching goal would be, before start of any oncological treatment in a patient, to have evaluated the response of oncological treatment in the zebrafish avatar and only treat with a combination of drugs known to have effect against the patient's own tumour. 2.3 Study design: This protocol describes a series of prospective studies in different cohorts of patients with colon cancer to investigate the applicability of zebrafish embryo models. The common denominator of the sub-studies is prospective collection of tumor tissue implanted in zebrafish embryos in order to evaluate if the model is robust enough for growing colon cancer tissue and evaluate growth pattern and response to chemotherapy. This study protocol is designed according to and in adherence with the SPIRIT guidelines. 2.4 Intervention: In all sub-studies the intervention is inoculation of tumor cells in zebrafish embryos followed by observation of tumor behavior and testing of treatments.

Conditions

Colon Cancer

Keywords

drug therapy; Zebra fish embryo model

Outcome Measures

Primary Outcomes (1)

• Tumour growth

  % of tumours growing of all implanted in the model

  within 3 days

Secondary Outcomes (1)

• response evaluation

  3 days

Study Arms (1)

Colon cancer

EXPERIMENTAL

Tumour tissue from each patients tumour will be implanted in zebrafish embryos and evaluated regarding growth and response to chemotherapy

Drug: Chemotherapy drug

Interventions

Chemotherapy drug DRUG

rsponse evaluation in zebrafish embryo model

Colon cancer

Eligibility Criteria

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

You may qualify if:

• Colon cancer planned for radical colon resection signed informed consent

You may not qualify if:

• Not willing to participate

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Per Sandström

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Per SANDSTROM, Prof

CONTACT

+46734058581; per.sandstrom@liu.se

Bergthor Bjornsson, assoc Prof

CONTACT

+46101033666; bergthor.bjornsson@liu.se

Study Design

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

Model Details: Evaluation of patients derived colon cancer tumour cell growth in zebra fish embryos and response evaluation of combinations of chemotherpy

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: January 10, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

SE (1)