NCT04443816

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

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

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

January 1, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

June 19, 2020

Last Update Submit

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

Tergooi hospital

Hilversum, Netherlands

Location

St Antonius Hospital

Nieuwegein, Netherlands

Location

Rivierenland ziekenhuis

Tiel, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

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

Locations