Hypercoagulation Screening in Cancer

Cancer Patients Clinical Trial

— HYPERCAN  

Official title:

Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622815
• Other study ID #: AIRC5xmille - 12237
• Status: Recruiting
• Start date: April 2012
• Est. completion date: January 2020

Study information

• Verified date: October 2018
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Anna Falanga, MD
• Phone: +39-035.267.8597
• Email: annafalanga[@]icthic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Patients
• Healthy Blood Donors
• Moli-sani Subjects
• Thrombophilia

Locations

Country	Name	City	State
Italy	Papa Giovanni XXIII Hospital - Oncology Unit	Bergamo
Italy	Papa Giovanni XXIII Hospital - S.I.M.T.	Bergamo
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan
Italy	Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco	Osio Sotto	Bergamo
Italy	I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED	Pozzilli	Isernia
Italy	ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital	Rome
Italy	Fondazione Humanitas per la Ricerca	Rozzano	Milan
Italy	A.S.S.T. Bergamo Ovest	Treviglio	Bergamo

Sponsors (9)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	A.S.S.T. Bergamo Ovest, ASL Roma 1, Associazione Italiana per la Ricerca sul Cancro, Fondazione Humanitas per la Ricerca, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituti Ospedalieri Bergamaschi Srl, Istituti Tumori Giovanni Paolo II, Istituto Neurologico Mediterraneo Neuromed S. R. L

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of blood donors with a diagnosis of cancer	Samples collected from identified participants with cancer diagnosis will be assessed to determine the hypercoagulation profile (ratio for laboratory analysis cancer case : healthy control from same cohort = 1:3, matched for age and gender)	within 5 years from the date of the enrollment
Primary	Incidence of Thrombotic events among enrolled cancer patients	Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.	within 5 years from the date of the enrollment
Secondary	Incidence of Cancer progression among enrolled cancer patients	Identification of cancer patients with evidence of cancer progression derived from review of clinical records.	within 5 years from the date of the enrollment