Advanced Geriatric Evaluation and Quality of Life in Colorectal Cancer Surgery
AGE CRC
1 other identifier
observational
273
1 country
6
Brief Summary
Colorectal cancer (CRC) disproportionately affects patients aged 70 years and older. Surgery is the main treatment modality for CRC, but is associated with increased risk of postoperative morbidity, disability and loss of health related quality of life (HRQL).Frailty is an age related state of functional decline and considered to be an important risk factor for adverse outcome in geriatric oncology.Risk models for adverse outcome may be used for treatment decisions in the elderly, but are often not designed to predict patient related outcome measures and do not include frailty characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2021
CompletedSeptember 27, 2021
September 1, 2021
3.5 years
June 19, 2020
September 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Loss of health related quality of life (HRQL)
Change in EORTC QLQ-C30
12 months
Secondary Outcomes (3)
Loss of health related quality of life (HRQL)
3 months
Postoperative complications
30 days
Disability
12 months
Eligibility Criteria
aged ≥ 70 years with a new diagnosis of non-metastatic CRC
You may qualify if:
- Age ≥ 70 years
- Histologically proven non-metastatic colorectal cancer
- Signed informed consent
You may not qualify if:
- \- Emergency surgical procedures
- Insufficient understanding of the Dutch language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Meander medical center
Amersfoort, Netherlands
Tergooi hospital
Hilversum, Netherlands
St Antonius Hospital
Nieuwegein, Netherlands
Rivierenland ziekenhuis
Tiel, Netherlands
Diakonessenhuis
Utrecht, Netherlands
UMCU
Utrecht, Netherlands
Related Publications (1)
van der Vlies E, Vernooij LM, Hamaker ME, van der Velden AMT, Smits M, Intven MPW, van Dodewaard JM, Takkenberg M, Vink GR, Smits AB, Bos WJW, van Dongen EPA, Los M, Noordzij PG. Frailty and health related quality of life three months after non-metastatic colorectal cancer diagnosis in older patients: A multi-centre prospective observational study. J Geriatr Oncol. 2022 Jan;13(1):74-81. doi: 10.1016/j.jgo.2021.08.005. Epub 2021 Aug 24.
PMID: 34446378DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 23, 2020
Study Start
January 1, 2018
Primary Completion
July 6, 2021
Study Completion
July 6, 2021
Last Updated
September 27, 2021
Record last verified: 2021-09