Tumor organoids: feasibility to predict sensitivity to treatment in cancer patients (TUMOROID trial)

Tumor organoids are three-dimensional cultures of cancer stem cells that can
now be established on an individual patient basis. If tumor organoids are able
to predict sensitivity to treatment, this can prevent unnecessary exposure to
toxic agents and result in improved patient selection for treatment with
targeted agents.

• Evaluate the potential of tumor organoid therapy response to predict
treatment response in the patient
• Design a standardized organoid screening test and propose a test threshold
that ensures a high negative predictive value
• Establish the success rate of tumor organoid culture from biopsies of locally
advanced disease or metastases of colorectal, breast and lung cancer in
clinical practice

This is a multicenter observational cohort study evaluating the feasibility of
using tumor organoids as a screening tool to predict treatment response to
standard of care agents (i.e. chemotherapy, targeted agents and androgen
depletion therapy) in patients with locally advanced (incurable) or metastatic
colorectal, breast or lung cancer. In this trial patients will be asked to
participate before they start treatment with any kind of standard of care agent
specified in this protocol. If patients consent to participation they will
undergo a biopsy procedure of the primary tumor or a metastatic lesion and a
blood withdrawal before start of treatment. The biopsy specimen will be used to
culture tumor organoids, which will subsequently be incubated with the same
standard of care treatment as has been given to the patient. Afterwards, the in
vitro response to treatment and the treatment response of the patient will be
compared to establish if it is feasible to use tumor organoids as an instrument
to predict response to treatment.
Patient treatment response will be recorded.

For all included patients, biopsies of the metastatic lesion or primary tumor
will be performed in order to obtain material for organoid cultures. Ample
experience exists with performing biopsies in patients with metastatic lesions
and the procedure is considered to be safe. Alongside the tumor biopsies, three
blood samples will be obtained to determine germline DNA and for biomarker
research. Patients will be treated according to standard of care and clinical
management of patients will be performed according to daily practice in
participating institutions.