Rectrospect - a Retrospective Study of Treatment Response

NCT04787523 | Completed

• 1 other identifier: Rectrospect
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with pathological response to treatment

Response evaluated using the pathology report

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Patients have received neoadjuvant radiotherapy

Patients with pathological response to treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with neoadjuvant treatment between 2007-2019

You may qualify if:

• Rectal cancer and treatment between 2007 and 2019

You may not qualify if:

• No rectal cancer or no neoadjuvant treatment

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies taken at diagnosis

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 8, 2021
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)