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Monitoring Radiation Induced Cardiac Damage by Blood Markers (CARD)

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ClinicalTrials.gov Identifier: NCT02481778
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jannet C.Beukema, University Medical Center Groningen

Brief Summary:

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.


Condition or disease Intervention/treatment
Radiation Induced Cardiac Damage Other: Blood sampling

Study Type : Observational
Estimated Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Radiation Induced Cardiac Damage by Blood Markers
Study Start Date : September 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481778


Contacts
Contact: J.C. Beukema, Dr. +31503610025 j.c.beukema@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: JC Beukema, Dr.    +31503610025    j.c.beukema@umcg.nl   
Sponsors and Collaborators
University Medical Center Groningen

Responsible Party: Jannet C.Beukema, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02481778     History of Changes
Other Study ID Numbers: RT2014-01
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Jannet C.Beukema, University Medical Center Groningen:
Radiotherapy
Cardiac
Toxicity