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NCT04787523 Clinical Trial

Rectrospect - a Retrospective Study of Treatment Response

Rectal Neoplasms Clinical Trial

— Rectrospect  

Official title:
Rectrospect - a Study on the Immun Cell Infiltrate in a Retrospective Rectal Cancer Cohort.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04787523
Other study ID # Rectrospect
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2022

Study information
Verified date November 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Biopisies from patients diagnosed with rectal cancer between 2007-2019 will be cut into 4-6 micrometer thin sections for morphology and immunostaining. Every section will be numbered with a code that is connected to the patients personal identification number and the code list will be kept separately from the biopsies in a password protected file on the Sahlgrenska University Hospital server. Patient data and outcome regarding response to treatment will be collected from patient charts and the Swedish ColoRectal Cancer Registry, but all data will be numbered with the same code number and all results will be kept away from the code list. In order to achieve the stated aims, that is, to study how the molecular and cellular characteristics of the tumour and its surrounding microenvironment as well as the interaction of tumour cells and immune cells affect treatment response, several molecular and cellular techniques and assays may be applied.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date December 31, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Rectal cancer and treatment between 2007 and 2019 Exclusion Criteria: - No rectal cancer or no neoadjuvant treatment

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiotherapy
Patients have received neoadjuvant radiotherapy

Locations
Country Name City State
Sweden Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immun cell infiltrate in pathology sections from the tumour Number of of CD3+ and CD8+ cells in the tumour in relation to response to treatment Biopsies taken preoperatively
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