Clinical trial • Phase I • Oncology|Gastroenterology

Clinical trial in Locally advanced rectal cancer|Rectal cancer

Phase I trial for Locally advanced rectal cancer|Rectal cancer. None/Not specified-controlled. 23 participants.

Overview

Trial Therapeutic Area
Oncology|Gastroenterology
Trial Disease
Locally advanced rectal cancer|Rectal cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
21-11-2023
First CTIS Authorization Date
18-03-2024

Trial design

None/Not specified-controlled Phase I trial across 1 site in Netherlands.

Comparator
None/Not specified
Target Sample Size
23

Eligibility

Recruits 23 No vulnerable population selected; consent/assent procedures not specified in available documents..

Vulnerable Population
No vulnerable population selected; consent/assent procedures not specified in available documents.

Recruitment

Planned Sample Size
23
Recruitment Window Months
17

Geography

Total Number Of Sites
1
Total Number Of Participants
23

Netherlands

Earliest CTIS Part Ii Submission Date
07-03-2024
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
641
Number Of Sites
1
Number Of Participants
23

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Wouter. B. Nagengast
Principal Investigator Email
w.b.nagengast@umcg.nl
Contact Person Name
Wouter. B. Nagengast
Contact Person Email
w.b.nagengast@umcg.nl
Number Of Participants
23

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Groningen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

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