Core Outcome Measures in Effectiveness Trials

Development of a core outcome set based on Case Report Form (CRF) to assess laboratory biomarkers and clinical parameters in Onco-Hematology area

General Information

Background: The number of cases, the crude and age-standardized incidence, mortality rates and the prevalence proportions estimated by the Italian Association of Cancer Registries (AIRTUM) presently providing the epidemiological indicators for the major cancers used in ICD-O-3.1. By 2012, the breast cancer incidence in women (age 25±over 85 years) was about 29%; trends for stomach and colorectal cancer were about 5% and 14% for both genders (age 35/45±over 85 years); the lung cancer incidence rates was about 15% in men (age 45±over 85 years) and 6% in women (age 40±over 85) in 2009. From 2011 onwards the tendency changed: the female rates (20 per 100,000) increased much more rapidly than the male rates.
Aim of this study is to examine the relationships among the incidence of genera-cancer-associated risk factors and routine laboratory in cancer patients through CRF.
Method: The CRF database has been developed by a dedicated working group using Delphi process. It contain anonymous records on patient characteristics (gender, age, alcohol and smoking history, height, body weight, performance status measured using the Eastern Cooperative Oncology Group-ECOG PS, chronic comorbidities weighted by the Charlson Comorbidity Index-CCI, type and stage of tumor) and one set of biomarker laboratory data (Hgb level, HCT, total WBC, RBC and platelet counts) identified in several variables.
Results: Between 2012 and 2014, 1373 cancer patients were enrolled at three Italian Oncological Institutions after informed consent. Among these patients, 36% were men and 64% were women (mean age 71±45 years) and breast was the most frequent type cancer (43%) followed by lung (29%), colon-rectum (18%) and stomach (9%). 72% (n=85) of the lung, 67% (n=24) of the stomach, 33% (n=25) of the colon-rectum, 4% (n=7) of the breast cancer patients had comorbidities weighted with 3 point and above (Age Unadjusted Charlson-Comorbidity-Index=4; HR=6.38; 99% CI [3.07,13.24]). Multivariate analysis determined that comorbidity was highly associated with cancer type, stage and ECOG PS (p=0.01). Evaluation between cardiovascular disease, risk of bleeding, deep-vein thrombosis and colon-rectum cancer stage (p=0.01), breast (p=0.03), lung (p=0.01) compared into comorbidities. The other tested variables: Hgb level, neutrophil and platelet counthad had the strongest relationship with breast, lung cancer stage (p=0.02), stomach (p=0.002) and colon-rectum (p=0.1).
Conclusion: The current study confirmed that cancer staging, comorbidity and poor performance status were a significant predictive factor. The appropriateness of results could be useful to better describe the role of CRF and biomarkers recorded in patient charts as well as the other variables could allow nurses to identify patients at risk for shorter survival time following hospitalization.

Mariangela Vanalli and Francesca Rio, Division of Immunohematology and Transfusion Medicine, Hospital Papa Giovanni XXIII, Bergamo and University of Milan Bicocca, Milan, Italy.

Further Study Information

Current Stage:
Not applicable
February 2012 - October 2014
Funding source(s):
Cancer Research in Bergamo, Milan and Rome.

Health Area

Disease Category

Disease Name
Breast cancer
Colorectal cancer
Lung cancer
Stomach cancer

Target Population

Age Range
18 - 100


Nature / type of Intervention
Not specified


Consensus conference
Delphi process

Development CRF database using Delphi process

Other details about the population within the health area: Comorbidity and cancer staging


Stakeholders Involved

Clinical experts

Study Type

COS for clinical trials or clinical research
COS for practice

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