Hypercoagulation Screening in Cancer

NCT02622815 | Unknown DMC

• 1 other identifier: AIRC5xmille - 12237
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Healthy Blood Donors; Moli-sani Subjects; Cancer Patients

Keywords

Hypercoagulation; Thrombosis; Cancer Risk Assessment; Cancer Prognosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Incidence of Cancer progression among enrolled cancer patients

  within 5 years from the date of the enrollment

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• good health
• signed informed consent.

You may not qualify if:

• inflammations/infections/fever;
• recent vaccinations;
• recent surgery;
• anticoagulant therapy.
• Cancer patients\_
• 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.
• acute medical illness;
• terminal conditions or life expectancy less than 3 months;
• under low molecular weight heparin at therapeutic dosage.

Sponsors & Collaborators

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

Study Sites (8)

Istituti Ospedalieri Bergamaschi S.r.l. - Policlinico San Marco

Osio Sotto, Bergamo, 24040, Italy

RECRUITING

A.S.S.T. Bergamo Ovest

Treviglio, Bergamo, 24047, Italy

RECRUITING

I.R.C.C.S. Istituto Neurologico Mediterraneo NEUROMED

Pozzilli, Isernia, 86077, Italy

ACTIVE NOT RECRUITING

Fondazione Humanitas per la Ricerca

Rozzano, Milan, 20089, Italy

RECRUITING

Papa Giovanni XXIII Hospital - Oncology Unit

Bergamo, 24127, Italy

RECRUITING

Papa Giovanni XXIII Hospital - S.I.M.T.

Bergamo, 24127, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

ASL Roma 1 - ACO San Filippo Neri & San Giovanni Maria Addolorata Hospital

Rome, 00135, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, serum and tissue

MeSH Terms

Conditions

Thrombophilia; Thrombosis

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Falanga, MD

  A.O. Papa Giovanni XXIII - Recruiting

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Falanga, MD

CONTACT

+39-035.267.8597; annafalanga@icthic.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Division of Immunohematology and Transfusion Medicine

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 7, 2015
• Study Start: April 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

IT (8)