Monitoring Radiation Induced Cardiac Damage by Blood Markers (CARD)

Rationale:

Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.

Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.

Objective:

The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.

Study Overview

• Status: Completed
• Conditions: Radiation Induced Cardiac Damage
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal- or non small cell lung cancer treated with radiotherapy with curative intention, with or without chemotherapy, with or without surgery, at the department of radiotherapy at the University Medical Centre Groningen

Description

Inclusion Criteria:

• Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
• Older than 18 years
• Written informed consent

Exclusion Criteria:

• Prior radiotherapy to the chest including radiotherapy for breast cancer
• Patients treated with palliative intent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in percentage of rise of the level of NT pro BNP after radiotherapy	At 1 year after end of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac events	A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed rhythm disorder will be scored as a cardiac event. Myocardial ischaemia requiring intervention and changes in cardiac medication in case of deterioration of known heart failure will be analysed by a cardiologist to decide whether or not to score this as an event. Events will be scored according the CTCAE 4.2 criteria.	After start treatment up to 2 years after end of radiation therapy.
Change in percentage of rise of hs-TNT during or after treatment		At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2015
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimated): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Toxicity; Cardiac
• Other Study ID Numbers: RT2014-01