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

Individualization of rectal cancer therapy by predicting the response to neoadjuvant therapy response to neoadjuvant radiochemotherapy by organoid cultures - IndiTRec (Individualized Treatment of Rectal Cancer)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027832

Enrollment

120

Registered

2022-01-18

Start date

2019-07-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C20

Interventions

Group 1: Patients with rectal cancer undergoing tumor surgery after total neoadjuvant therapy.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactDaniel Stange

Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Universitätsklinikum Carl Gustav Carus der TU Dresden

daniel.stange@uniklinikum-dresden.de+49-351-458 18263

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026