Survival,quality of life and iPE in cancer patients

  • Research type

    Research Study

  • Full title

    A study of Survival and Quality of life of Cancer Patients with Incidental Pulmonary Embolism Treated with Low Molecular Weight Heparin (LMWH)

  • IRAS ID

    156598

  • Contact name

    Anthony Maraveyas

  • Contact email

    anthony.maraveyas@hey.nhs.uk

  • Sponsor organisation

    HEY NHS Trust

  • Eudract number

    2014-004706-15

  • Research summary

    Cancer patients undergo computed tomography CT scan of the chest and abdomen for clinical assessment more frequently than other patients; this has led to an increased chance of finding a blood clot on the lungs (pulmonary embolism (PE)).
    Little is known about the risk factors and the impact of these clots on the quality of life and survival of these patients; only a few studies have studied the risk factors and the natural history of incidentally found Pulmonary Embolism (i-PE) in cancer patients.
    This study aims to evaluate the clinical outcomes and laboratory measures of cancer patients who have i-PE compared with cancer patients who are similiar in age, gender and extent of cancer without PE or other blood clots in the veins with regard to:
    1) Clinical outcomes include; survival, quality of life, performance status (general level of activity and daily function), and symptoms.
    2) Laboratory outcomes include; blood tests of clotting activity and clot formation, and whether the circulating cancer cells from stored biopsies are those which can trigger clots.

    The overarching aim is to establish whether these tests can identify which patients need injected drug treatment for iPE and those where it is safe to observe only.

    This study is a case controlled study.
    Cancer patients referred from the computed tomography scan department to the i-PE clinic at the Queen’s Oncology and Haematology Centre (QCOH) at Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Trust [HEYHT] will be approached by a member of the clinical team and invited to participate.
    Consenting participants will give an additional amount of blood (10ml) to their regular work up labs, and filling in Quality of life questionnaires and symptom assessment questionnaires.
    Study patients will be followed up for six months, at intervals (Baseline/ +7 days/+30 days/ +90 days/ + 180 days). See provided schema and Schedule of Events Table 1).

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    14/NE/1217

  • Date of REC Opinion

    26 Nov 2014

  • REC opinion

    Unfavourable Opinion