NCT05185557

Brief Summary

A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

December 16, 2021

Last Update Submit

February 2, 2023

Conditions

Metastatic Rectal AdenocarcinomaBrain Metastases

Outcome Measures

Primary Outcomes (1)

  • Incidence of brain metastasis

    Incidence of brain metastasis in a high risk selected group

    2 years

Secondary Outcomes (4)

  • Number of brain metastases eligible for local treatment options

    2 years

  • Median two year overall survival

    2 years last patient

  • Prognostic value of circulating DNA levels at baseline

    2 years last patient

  • Descriptive biological analysis of tumor tissue and circulating tumor DNA

    2 years last patient

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients with metastatic rectal cancer and presence of lung metastasis.

You may qualify if:

  • Primary rectal tumor location
  • Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
  • Able to understand written information
  • Consent to samples for translational research

You may not qualify if:

  • Contraindications for MRI Priorly treated or known brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Rectal NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anders K Boysen, MD, PhD

    Department of Oncology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 11, 2022

Study Start

August 16, 2021

Primary Completion

August 1, 2023

Study Completion

February 1, 2025

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

DK(1)