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Hypercoagulation Screening in Cancer (HYPERCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622815
Recruitment Status : Unknown
Verified October 2018 by ANNA FALANGA, Papa Giovanni XXIII Hospital.
Recruitment status was:  Recruiting
First Posted : December 7, 2015
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
Associazione Italiana per la Ricerca sul Cancro
Istituto Neurologico Mediterraneo Neuromed S. R. L
Fondazione Humanitas per la Ricerca
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ASL Roma 1
Istituti Ospedalieri Bergamaschi Srl
ASST Bergamo Ovest
Istituti Tumori Giovanni Paolo II
Information provided by (Responsible Party):
ANNA FALANGA, Papa Giovanni XXIII Hospital

Study Description
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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.


Condition or disease
Healthy Blood Donors Moli-sani Subjects Cancer Patients

Study Design
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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hypercoagulation Screening as Innovative Tool for Risk Assessment, Early Diagnosis and Prognosis in Cancer
Actual Study Start Date : April 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Healthy blood donors
10,000 highly controlled blood donors in the age range 30-70 years
Moli-sani subjects
A sample of 1,000 tumor cases have been identified so far and samples from these participants will be analyzed compared to 1,000 controls from randomly extracted from the Moli-sani cohort (parent cohort).
Cancer patients
4,000 Patients with breast, lung, and gastrointestinal tumors.


Outcome Measures
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Primary Outcome Measures :
  1. Number of blood donors with a diagnosis of cancer [ Time Frame: within 5 years from the date of the enrollment ]
    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)

  2. Incidence of Thrombotic events among enrolled cancer patients [ Time Frame: within 5 years from the date of the enrollment ]
    Identification of cancer patients with evidence of thrombotic event derived from review of clinical records.


Secondary Outcome Measures :
  1. Incidence of Cancer progression among enrolled cancer patients [ Time Frame: within 5 years from the date of the enrollment ]
    Identification of cancer patients with evidence of cancer progression derived from review of clinical records.


Biospecimen Retention:   Samples With DNA
whole blood, plasma, serum and tissue

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622815


Contacts
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Contact: Anna Falanga, MD +39-035.267.8597 annafalanga@icthic.com

Locations
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Italy
Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco Recruiting
Osio Sotto, Bergamo, Italy, 24040
Contact: Andrea D'Alessio, MD       dr.dalessio@gmail.com   
Contact: Sara Cecchini, MD       saracecchini@hotmail.it   
A.S.S.T. Bergamo Ovest Recruiting
Treviglio, Bergamo, Italy, 24047
Contact: Fausto Fausto, MD       fausto_petrelli@asst-bgovest.it   
Contact: Mara Ghilardi, MD       mara.ghily@asst-bgovest.it   
I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED Active, not recruiting
Pozzilli, Isernia, Italy, 86077
Fondazione Humanitas per la Ricerca Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD       armando.santoro@cancercenter.humanitas.it   
Contact: Giovanna Masci, MD       giovanna.masci@cancercenter.humanitas.it   
Papa Giovanni XXIII Hospital - Oncology Unit Recruiting
Bergamo, Italy, 24127
Contact: Roberto Labianca, MD       rlabianca@asst-pg23.it   
Contact: Carlo Tondini, MD       ctondini@asst-pg23.it   
Papa Giovanni XXIII Hospital - S.I.M.T. Recruiting
Bergamo, Italy, 24127
Contact: Anna Falanga, MD       annafalanga@icthic.com   
Contact: Carmen J. Tartari, PhD       aircfalanga@gmail.com   
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Filippo De Braud, MD       filippo.debraud@istitutotumori.mi.it   
Contact: Luigi Celio, MD       luigi.celio@istitutotumori.mi.it   
ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital Recruiting
Rome, Italy, 00135
Contact: Giampietro Gasparini, MD       gasparini.oncology@hotmail.it   
Contact: Roberta Sarmiento, MD       roberta.sarmiento@yahoo.it   
Sub-Investigator: Mauro Minelli, MD         
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Associazione Italiana per la Ricerca sul Cancro
Istituto Neurologico Mediterraneo Neuromed S. R. L
Fondazione Humanitas per la Ricerca
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ASL Roma 1
Istituti Ospedalieri Bergamaschi Srl
ASST Bergamo Ovest
Istituti Tumori Giovanni Paolo II
Investigators
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Principal Investigator: Anna Falanga, MD A.O. Papa Giovanni XXIII - Recruiting
More Information
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Responsible Party: ANNA FALANGA, Director of the Division of Immunohematology and Transfusion Medicine, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT02622815    
Other Study ID Numbers: AIRC5xmille - 12237
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by ANNA FALANGA, Papa Giovanni XXIII Hospital:
Hypercoagulation
Thrombosis
Cancer Risk Assessment
Cancer Prognosis
Additional relevant MeSH terms:
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Thrombophilia
Hematologic Diseases