Individualization of rectal cancer therapy by predicting the response to neoadjuvant therapy response to neoadjuvant radiochemotherapy by organoid cultures

Recruiting

• Conditions: C20; Malignant neoplasm of rectum

• Registration Number: DRKS00027832
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Histologically confirmed locally advanced rectal cancer
- Planned implementation of neoadjuvant therapy
- No contraindication to resection of rectal cancer
- Female and male patients = 18 years of age
- Patient is able and willing to provide written informed consent and comply with the study protocol

Exclusion Criteria

- Malignant secondary disease that occurred < 5 years ago (exception: early stage of a localized tumor with in-sano resection, for example in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin).
- Patients who are housed in a closed facility.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this pilot study is to evaluate the extent to which therapy of rectal cancer organoids can predict the response to neoadjuvant therapy. If the organoids can be established as a predictive marker, this could lead to a individualization of the treatment of patients with rectal cancer. Thus, the predictive value of a patient-individualized organoid model with regard to the effectiveness of neoadjuvant therapy will be investigated. The organoid-based differentiation into complete responders, responders and non-responders will be compared with the clinical clinical response (PET/MRI and endoscopy) and pathological response in the resection specimen.

Secondary Outcome Measures

Name	Time	Method
The secondary objective of the study is to correlate the molecular changes found in the organoid model with the recurrence pattern (no recurrence, local recurrence, systemic recurrence). This will provide a better understanding of the molecular mechanisms leading to recurrence.