Rectal NeoplasmsRectrospectNCT04787523
Rectrospect - a Retrospective Study of Treatment Response
An observational study of Rectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with neoadjuvant treatment between 2007-2019
Who may be able to join
- Rectal cancer and treatment between 2007 and 2019
Who cannot join
- No rectal cancer or no neoadjuvant treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Official title: Rectrospect - a Study on the Immun Cell Infiltrate in a Retrospective Rectal Cancer Cohort.
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
- Being tested
- Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients have received neoadjuvant radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with pathological response to treatment | Response evaluated using the pathology report Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Biopsies taken preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Oct 2020
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787523
- Sponsor's protocol ID
- Rectrospect
- Acronym
- Rectrospect
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectrospect - a Study on the Immun Cell Infiltrate in a Retrospective Rectal Cancer Cohort.
- ClinicalTrials.gov ID
- NCT04787523
- Acronym / sponsor ID
- Rectrospect / Rectrospect
- Conditions
- Rectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pathological response to treatment | – | Radiation: RadiotherapyResponse evaluated using the pathology report |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with neoadjuvant treatment between 2007-2019
Key inclusion criteria (1 listed)
- Rectal cancer and treatment between 2007 and 2019
Key exclusion criteria (1 listed)
- No rectal cancer or no neoadjuvant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyPatients have received neoadjuvant radiotherapy | Radiation | Patients with pathological response to treatment |
Primary outcome
Immun cell infiltrate in pathology sections from the tumour
Time frame: Biopsies taken preoperatively
Number of of CD3+ and CD8+ cells in the tumour in relation to response to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immun cell infiltrate in pathology sections from the tumour (time frame: Biopsies taken preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.