UMIN-CTR Clinical Trial

Public title

Prediction of chemosensitivity testing for clinical efficacy with patient-derived cancer stem cells; an observational study

Acronym

PROCESS trial

Scientific Title

Prediction of chemosensitivity testing for clinical efficacy with patient-derived cancer stem cells; an observational study

Scientific Title:Acronym

Prediction of chemosensitivity testing for clinical efficacy with patient-derived cancer stem cells; an observational study

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology	Surgery in general	Adult

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

We are developing a research protocol for a drug sensitivity test method that can best predict the therapeutic effect of chemotherapy regimens including irinotecan in actual clinical practice for patients using an in vitro model established by culturing patient-derived colorectal cancer spheroids. The purpose of this study is to prospectively verify whether the developed protocol can actually predict the therapeutic effect of chemotherapy regimens in patients.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

The correlation between drug sensitivity assay results using patient-derived samples (IC50 and AUC) and clinical chemotherapy outcomes in patients, including RECIST-based treatment response, duration of response, and prognosis

Key secondary outcomes

Correlation of the estimation results from novel cell imaging technology to those from conventional luciferase assay

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients with colorectal cancer scheduled to undergo chemotherapy at Kyoto University Hospital, Kochi University Hospital, Kansai Medical University Hospital, Osaka Medical and Pharmaceutical University Hospital, Kurume University Hospital, and Nippon Medical School Hospital
2.Informed consent forms for clinical research related to the establishment of cancer spheroids using colorectal cancer tissues were obtained from research collaborators at Kyoto University Hospital, Kochi University Hospital, Kansai Medical University Hospital, Osaka Medical and Pharmaceutical University Hospital, Kurume University Hospital, and Nippon Medical School Hospital. The cases in which spheroid culture models were established or are planned to be established in this study

Key exclusion criteria

1. Cases where treatment efficacy cannot be assessed using RECIST
2. Other cases deemed ineligible for this study by the principal investigator and researcher

Target sample size

50

Name of lead principal investigator

1st name	Kazutaka
Middle name
Last name	Obama

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery

Zip code

606-8507

Address

54 Shogoin Kawahara-Cho, Sakyo-Ku, Kyoto

TEL

075-366-7595

Email

ctsodan@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Obama
Middle name
Last name	Kazutaka

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Surgery, Department of Personalized Cancer Medicine

Zip code

606-8507 / 606-8507

Address

54 Shogoin Kawahara-Cho, Sakyo-Ku, Kyoto/ 53 Shogoin Kawahara-Cho, Sakyo-Ku, Kyoto

TEL

075-366-7595(075-366-7414)

Homepage URL

https://pcm.med.kyoto-u.ac.jp/

Email

office@pcm.med.kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

1.Medical Oncology, Kochi Medical School Hospital
2.Clinical Oncology, Kansai Medical University Hospital
3.Division of Translational Research, Center for Medical Research and Development, Division of Translational Research, Osaka Medical and Pharmaceutical University Osaka Medical and Pharmaceutical University
4.Department of Surgery, Kurume University
5.Department of Clinical Laboratory Medicine, Kurume University Hospital
6.Department of Gastroenterological Surgery, Nippon Medical School

Name of secondary funder(s)

SCREEN Holdings Co., Ltd.
Kyo-Diagnostics K. K.
AFI Corporation

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto

Tel

075-366-7618

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

1.京都大学医学部付属病院（京都府）
2.高知大学医学部付属病院（高知県）
3.関西医科大学附属病院（大阪府）
4.大阪医科薬科大学病院（大阪府）
5.久留米大学病院（福岡県）
6.日本医科大学付属病院（東京都）

Date of disclosure of the study information

2025

Year

07

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2024

Year

05

Month

15

Day

Date of IRB

2024

Year

05

Month

16

Day

Anticipated trial start date

2024

Year

07

Month

10

Day

Last follow-up date

2027

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The development of new chemotherapy regimens for patients with unresectable colorectal cancer has significantly improved the overall prognosis for this population. However, there remain substantial inter-individual differences in therapeutic response, highlighting the growing importance of personalized medicine aimed at providing the most effective treatment for each patient. Advances in cancer genomics have enabled the identification of molecularly targeted drugs that may be effective for tumors with specific oncogene. Nevertheless, predicting the efficacy of conventional cytotoxic chemotherapy which are pivotal in the treatment of colorectal cancer-remains a major challenge.
To date, we have collected samples from surgical resection specimens of colorectal cancer patients and conducted basic research using an in vitro model established by culturing patient-derived colorectal cancer spheroids, demonstrating the potential for clinical application. Furthermore, we developed a method for in vitro sensitivity testing of irinotecan, and a retrospective analysis of 14 cases suggested that the results of the sensitivity testing correlated well with the treatment outcomes of the original colorectal cancer patients who received irinotecan-containing therapy ( unpublished ).If this method can accurately predict the sensitivity of individual tumors to irinotecan-based chemotherapy, it may serve as a highly valuable tool in clinical site and substantially advance the realization of personalized treatment. In fact, recent studies, although small in scale, have reported the potential of in vitro drug sensitivity testing using patient-derived colorectal cancer cells to predict patient prognosis.

Registered date

2025

Year

07

Month

07

Day

Last modified on

2025

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066760