Ex vivo organoid response correlates to in vivo response to standard first line treatment in mCRC patients on a metastasis level, therefore organoids can be used to predict response to therapy and select patients for a specific treatment.
ID
Bron
Verkorte titel
Aandoening
Metastatic colorectal cancer
Ondersteuning
Dept. of Medical Oncology
UMC Utrecht
PO Box 85500 (Q04.4.300),
3508 GA Utrecht, the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Response at first evaluation after treatment with standard of care drugs of the index metastasis that is biopsied for organoid culture as measured by change in size on a CT-scan (continuous variable).
Achtergrond van het onderzoek
N.A.
Doel van het onderzoek
Ex vivo organoid response correlates to in vivo response to standard first line treatment in mCRC patients on a metastasis level, therefore organoids can be used to predict response to therapy and select patients for a specific treatment.
Onderzoeksopzet
For all patients, the treatment regimen(s) after biopsy will be recorded. The follow-up for treatment regimen(s) will be recorded until: 1) the end of treatment as determined by the end of follow up clinical visits or 2) death.
Response to treatment will be determined by evaluating the objective overall response rate (complete response and partial response) according to RECIST 1.1 criteria. Response to treatment will be evaluated through means of standard of care CT-scans. Follow-up CT scans will be performed according to institutional standards or at the physicians’ discretion. In addition, the biopsy from where the organoid originate is separately assessed for response.
Onderzoeksproduct en/of interventie
N.A.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
(Shortened)
1- Patients with histologically proven metastatic colorectal cancer who will receive first line systemic treatment.
2- Patient is included in PLCRC and has signed informed consent to be asked for future studies and blood withdrawal within PLCRC.
3- Patients need to have measurable RECIST CT imaging (according to RECIST 1.1) or evaluable disease (26).
4- Metastatic lesion(s) in the liver of which a biopsy can safely be obtained.
5- Patients not known with contraindications for lidocaine (or its derivatives).
6- Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
If patients start a new line of treatment after participation in this trial, they are eligible to participate again. Informed consent, baseline screening and the histological biopsy procedure will have to be repeated.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1- Patients with additional unrelated tumors.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7305 |
| NTR-old | NTR7521 |
| Ander register | : ABR NL61668.041.17 |