Clinical trial NCT02622815: Hypercoagulation Screening in Cancer
Official title: Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Blood Donors
Moli-sani Subjects
Cancer Patients
Keywords: Hypercoagulation
Thrombosis
Cancer Risk Assessment
Cancer Prognosis
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
name: Istituto Neurologico Mediterraneo Neuromed S. R. L
name: Fondazione Humanitas per la Ricerca
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: ASL Roma 1
name: Istituti Ospedalieri Bergamaschi Srl
name: ASST Bergamo Ovest
name: Istituti Tumori Giovanni Paolo II
First posted: 2015-12-07
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Blood donors (age range 30-70 years), who agree to participate, fulfill a specific questionnaire on their lifestyle and donate venous blood samples at the enrollment into the study, and after 6-12 months.

The parental cohort of the Moli-sani project included 24,325 subjects (\>35 years) from the Molise region. Blood samples have been collected and stored in the Moli-sani biobank available to this project.

Cancer patients of both genders (\>18 years) with new diagnosis of non small cell lung cancer, gastrointestinal tumors, and breast cancer are enrolled at different recruiting sites. Blood samples are collected at the enrollment and at specific time points during follow-up without interfering with clinical management.

Brief summary: There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).

Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.


Eligibility criteria: Blood donors_

Inclusion Criteria:

* good health
* signed informed consent.

Exclusion Criteria: (considering 10-15 days from blood sampling)

* inflammations/infections/fever;
* recent vaccinations;
* recent surgery;
* anticoagulant therapy.

Cancer patients_

Inclusion Criteria:

* with life expectation higher than 3 months;
* patients with breast, lung or gastrointestinal tumors candidated for chemotherapy regimen;
* ECOG PS 0-2;
* adeguate bone marrow and renal function;
* signed informed consent.

Exclusion Criteria:

* acute medical illness;
* terminal conditions or life expectancy less than 3 months;
* under low molecular weight heparin at therapeutic dosage.

Primary outcomes:
measure: Number of blood donors with a diagnosis of cancer
timeFrame: within 5 years from the date of the enrollment
measure: Incidence of Thrombotic events among enrolled cancer patients
timeFrame: within 5 years from the date of the enrollment
Secondary outcomes:
measure: Incidence of Cancer progression among enrolled cancer patients
timeFrame: within 5 years from the date of the enrollment
Other outcomes:
Locations:
city: Osio Sotto
country: Italy
facility: Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco
state: Bergamo
city: Treviglio
country: Italy
facility: A.S.S.T. Bergamo Ovest
state: Bergamo
city: Pozzilli
country: Italy
facility: I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED
state: Isernia
city: Rozzano
country: Italy
facility: Fondazione Humanitas per la Ricerca
state: Milan
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital - Oncology Unit
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital - S.I.M.T.
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Rome
country: Italy
facility: ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital
Study officials:
affiliation: A.O. Papa Giovanni XXIII - Recruiting
name: Anna Falanga, MD
role: PRINCIPAL_INVESTIGATOR
References: