Monitoring Radiation Induced Cardiac Damage by Blood Markers

NCT02481778 | Completed

• 1 other identifier: RT2014-01
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Induced Cardiac Damage

Keywords

Radiotherapy; Cardiac; Toxicity

Outcome Measures

Primary Outcomes (1)

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

  At 1 year after end of radiation therapy

Secondary Outcomes (2)

• Cardiac events

  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.

Interventions

Blood sampling OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 25, 2015
• Study Start: September 8, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)