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Recruiting NCT06613581

NCT06613581 Patient-led Follow-up from Home After Surgery for Colorectal Carcinoma

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Clinical Trial Summary
NCT ID NCT06613581
Status Recruiting
Phase
Sponsor Erasmus Medical Center
Condition Colorectal Carcinoma (CRC)
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2024-07-18
Primary Completion 2029-09

Eligibility & Interventions

Sex All sexes
Min Age 21 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Home-based follow-up

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2024-07-18 with a primary completion date of 2029-09.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The primary goal of the patient-led follow-up from home, is the improvement of quality of life and the reduction of stress in patients, while obtaining a more complete picture of their health status. A series of assessments are performed in the home setting: * Blood withdrawal for CEA determination * Quality of life questionnaires to assess both mental and physical symptoms * Vital parameters using a Smart Sensor

Eligibility Criteria

inclusion criteria * Age ≥ 21 years * Histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago * Scheduled or currently undergoing postoperative surveillance according to national guidelines * Written informed consent by the patient * Access to a smartphone Exclusion criteria * Patients with a severely complicated postoperative course, needing in hospital follow- up longer than 6 months postoperatively * Patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax * Patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent * Patients with active implantable devices - e.g. pacemaker or implantable defibrillator * Inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the Dutch language

Contact & Investigator

Central Contact

Elise M.H.E. van Driel, MD

✉ m.h.e.vandriel@erasmusmc.nl

📞 +310107042125

Principal Investigator

Dirk J. Grunhagen, MD, PhD

PRINCIPAL INVESTIGATOR

Erasmus Medical Center

Frequently Asked Questions

Who can join the NCT06613581 clinical trial?

This trial is open to participants of all sexes, aged 21 Years or older, studying Colorectal Carcinoma (CRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06613581 currently recruiting?

Yes, NCT06613581 is actively recruiting participants. Contact the research team at m.h.e.vandriel@erasmusmc.nl for enrollment information.

Where is the NCT06613581 trial being conducted?

This trial is being conducted at Breda, Netherlands, Capelle aan den IJssel, Netherlands, Leiden, Netherlands, Rotterdam, Netherlands and 1 additional location.

Who is sponsoring the NCT06613581 clinical trial?

NCT06613581 is sponsored by Erasmus Medical Center. The principal investigator is Dirk J. Grunhagen, MD, PhD at Erasmus Medical Center. The trial plans to enroll 200 participants.

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