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OpenTrials
Completed

NCT Number: NCT02481778

Monitoring Radiation Induced Cardiac Damage by Blood Markers

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.

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Key information

Conditions

Radiation Induced Cardiac Damage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Primary outcomes

  1. Change in percentage of rise of the level of NT pro BNP after radiotherapy

    Time frame: At 1 year after end of radiation therapy

Secondary outcomes

  1. Cardiac events

    Time frame: After start treatment up to 2 years after end of radiation therapy.

    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.

  2. Change in percentage of rise of hs-TNT during or after treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: CARD

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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