Monitoring Radiation Induced Cardiac Damage by Blood Markers (CARD)

• ClinicalTrials.gov Identifier: NCT02481778
• Recruitment Status: Completed
• First Posted: June 25, 2015
• Last Update Posted: February 28, 2024
• Sponsor: University Medical Center Groningen
• Information provided by (Responsible Party): University Medical Center Groningen

Tracking Information

• First Submitted Date: May 11, 2015
• First Posted Date: June 25, 2015
• Last Update Posted Date: February 28, 2024
• Actual Study Start Date: September 8, 2015
• Actual Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 22, 2015): Change in percentage of rise of the level of NT pro BNP after radiotherapy [ Time Frame: At 1 year after end of radiation therapy ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 22, 2015)

• 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.
• 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. ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Monitoring Radiation Induced Cardiac Damage by Blood Markers
• Official Title: Monitoring Radiation Induced Cardiac Damage by Blood Markers

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Radiation Induced Cardiac Damage
• Intervention: Other: Blood sampling
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 29, 2019): 96
• Original Estimated Enrollment (submitted: June 22, 2015): 87
• Actual Study Completion Date: August 2020
• Actual Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02481778
• Other Study ID Numbers: RT2014-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Medical Center Groningen
• Original Responsible Party: Jannet C.Beukema, University Medical Center Groningen, Dr.
• Current Study Sponsor: University Medical Center Groningen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Medical Center Groningen
• Verification Date: February 2024