Detection of (sub) clinical toxicity in irradiated vs. non-irradiated surgically treated esophageal cancer patients: a pilot study.

Detection of (sub) clinical toxicity in irradiated vs. non-irradiated surgically treated esophageal cancer patients: a pilot study. - CROSS SECT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44510

Enrollment

Registered

2017-10-31

Start date

2017-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiopulmonary dysfunction

Interventions

Detection

Esophageal cancer

Radiation

Toxicity

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Treated for EC with a curative resection between 2000 and 2012 - Age >= 18 years - Written informed consent - No signs of tumor recurrence or new other malignancies.

Exclusion criteria

Exclusion criteria: - Thoracic radiotherapy for indications other than EC. - Contra indication for cardiac MRI, pacemaker, cochlear implants, metal not compliable with MRI.

Design outcomes

Primary

Measure	Time frame
As this is an exploratory pilot study to determine the most suitable diagnostic tests for future studies, there will be several endpoints related to (sub)clinical cardiopulmonary dysfunction. Signs of myocardial ischemia, systolic or diastolic dysfunction, rhythm and valve disorders, pericardial effusion and fibrosis, myocardial fibrosis, focal wall motion disorders and coronary calcifications will be analyzed. The cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection will be compared to cardiopulmonary (dys)function in EC survivors treated with surgical resection alone.	—

Measure

Time frame

As this is an exploratory pilot study to determine the most suitable diagnostic tests for future studies, there will be several endpoints related to (sub)clinical cardiopulmonary dysfunction. Signs of myocardial ischemia, systolic or diastolic dysfunction, rhythm and valve disorders, pericardial effusion and fibrosis, myocardial fibrosis, focal wall motion disorders and coronary calcifications will be analyzed. The cardiopulmonary (dys)function in EC survivors treated with neo-CRT followed by surgical resection will be compared to cardiopulmonary (dys)function in EC survivors treated with surgical resection alone.

—

Secondary

Measure	Time frame
-	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)