Infections

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Neoplasms

Communicable Diseases

Hepatitis A

Hepatitis C

Hepatitis

Virus Diseases

Colorectal Neoplasms

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

RNA Virus Infections

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Blood-Borne Infections

Flaviviridae Infections

Patients born between 1945-1965 who have clinic visits at a partnering federally qualified health center.

CARES-HCV is an educational intervention to promote both hepatitis c screening and colorectal cancer screening among diverse baby boomers in the area.

CARES-HCV

Shannon M Christy, PhD

Clement K Gwede, PhD, MPH, RN, FAAN

The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.

CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers

CARES-HCV: Promoting Concurrent Hepatitis C Virus Screening and Colorectal Cancer Screening Uptake Among Diverse Baby Boomers

Participants will be interviewed regarding their HCV knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials.

Participants will be interviewed regarding their CRC knowledge on Day 1 prior to receiving educational materials. They will be interviewed once again approximately one week after receiving educational materials.

Data about participants' HCV screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials.

Data about participants' CRC screening status will be collected from Federally Qualified Health Care Center's (FQHC) 6 months after participants have received educational materials.

H. Lee Moffitt Cancer Center and Research Institute

Recurrence

Carcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Fibrosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Interferon alpha-2b

Vincenzo Mazzaferro, MD

We conducted a randomized controlled trial of adjuvant interferon (IFN) therapy in patients with hepatitis-C virus (HCV)-related cirrhosis who underwent curative resection of hepatocellular carcinoma (HCC) to investigate whether IFN could reduce or delay the incidence of recurrent tumor (secondary/tertiary prevention of HCC). Patients were randomly assigned to treatment with IFN (3MU thrice/wk /48 weeks) vs. no treatment after curative resection of HCC(control group)

Background

Primary liver cancer (hepatocellular carcinoma, HCC) remains a major cancer-related cause of death with an estimated incidence of 1 million cases per year worldwide and particular endemic distribution related to chronic hepatitis carriers. Post-necrotic cirrhosis due to chronic infection by HBV and HCV is the leading background for HCC development with a yearly rate of 3% and a 5-year probability of survival of 20%.

Liver surgery, resection or transplantation, appears the only chance of curative treatment of the tumor, but feasibility is still ranging from 15 to 30% in Western countries at time of diagnosis. Several alternative treatments are available but their potential curative effects are lacking, due to the absence of controlled trials.

Liver resection is claimed to be feasible in order 15-30% of patients with HCC with mortality reported in major centers extremely low (5%). Technical and biological devices developed in the setting of OLT can now support the limited reserve of cirrhotic livers after resection.

Regulated segmentectomy is advisable with removal of the whole portal territory belonging to the tumor. Single nodule tumors (\< 5 cm) and compensated cirrhosis (Child class A) are accepted as the best candidates for liver resection that now can be performed with minimal blood loss, and minimal ischemia damage. Intraoperative ultra sound examination is now routinely used as the golden standard for staging and detection of previously undiscovered neoplastic nodules. Hepatic decompensation with ascites development, cholestasis and variceal bleeding within three months from surgery are the main negative prognostic factors for patient survival. Five years survival exceed 50% but tumor recurrences due to cirrhosis persistence could exceed 30% after three years of follow-up. Several attempts to reduce recurrence through antiangiogenetic and antiproliferative agents have been proposed.

In the present project a prospective randomized trial of Interferon (as antiproliferative drug) versus control in anti-HCV positive patients will investigate in homogeneous categories of resected tumor possible variation in the natural history and namely a reduction of recurrence rate after curative resection.

Purpose and Study Design

The trial was intentionally designed in 1997 as an unresticted collection of patients with histologically proved HCC and a HCV-related cirrhosis selected for surgical resection of the tumor in 4 experienced surgical Liver Units in Italy. Eligible patients were stratified on the basis of concomitant anti-core antibodies against HBV (anti-HBc) into two populations: "pure HCV" (HCV-RNA:positive, anti-HBc:negative) and "mixed HCV+HBV" (HCV-RNA:positive, anti-HBc:positive). Within each strata patients were then randomized in a 1:1 ratio to treatment with α-interferon (IFN) vs. no treatment (control). No restriction criteria were applied to tumor stage, as far as the resection of HCC was judged as potentially curative at pre-operative staging, intra-operative ultrasound and post-operative pathology (clearance of surgical margins).

The study was originally designed for lymphoblastoid α-interferon; then soon after trial approval by the NCI-Milan Scientific and Ethic Committee (#98-016) the protocol was amended for allowing also the use of recombinant α-2a (Roferon-A, Hoffmann-La Roche, Nutley NJ) or α -2b interferon (Intron-A, Schering-Plough, Kenilworth, NJ). The latter was eventually the preferred form. Patients allocated to treatment received IFN 3 MU/thrice weekly for 48 weeks starting within 6 weeks from the operation. The severity of adverse events during treatment were monitored and rated. Therapy was discontinued in case of life-threatening adverse event or in case of HCC recurrence during treatment. For severe events other than anemia the IFN dose was reduced by 50%; full dose could be resumed after the event was resolved or discontinued if the effect persisted. The percentage of the total predicted dose of IFN actually assumed by each patients was recorded. Patients assuming at least 80% of the total dose of IFN and treated for at least 80% of the expected duration of therapy were a priori defined as adherent to therapy.

Recurrences were a priori defined as "early" or "late" whether or not they occurred within 2 years from the surgical removal of the HCC. In fact early recurrence were related to intra-hepatic metastases of the primary tumor possibly missed at the time of therapy, while late recurrence might be due to new cancer foci related to the persistence of HCV-related carcinogenetic factors.

Primary endpoint of this randomized clinical trial (RCT) was recurrence-free survival (RFS) while the secondary endpoint were disease-specific survival (DSS) and overall survival (OS). Further secondary endpoints were the assessment of IFN tolerability in post-surgical patients and the observation of prognostic factors related to early or late recurrence. Adherent patients were considered for a subgroup analysis focused on patients who effectively received the treatment designed to prevent HCC recurrence.

Enrolment for the trial started on June 1998. By December 2002 the predicted sample size of 150 randomized patients was completed ("pure HCV": 80 and "mixed HCV+HBV": 70). The baseline clinical, laboratory and tumor characteristics of the two arms and viral strata were comparable. After 45 months of median follow-up the three- and five- years survival rates were 69% and 52.4% respectively for the control group and 77.3% and 63.6% respectively for the IFN group (P= 0.471) . At the univariate analysis tumor multiplicity (\>1 nodule) and vascular invasion were significantly related to recurrence. After adjustment of the relative weight of prognostic factors in a series of Cox models and cumulative incidence curves calculated on pattern of recurrence, a benefit of IFN was observed on late recurrence occurring in the pure-HCV patients adherent to treatment (hazard rate: 0.3; 95% Confidence interval:0.09-0.9, P=0.04).

In conclusion, although adjuvant IFN failed to show a generalized effect on prevention of HCC recurrence after curative resection, it effectively reduced late recurrence due to new tumor foci in pure-HCV patient adherent to therapy (i.e.: receiving at least 80% of IFN dose for at least 80% of time).

Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis

Adjuvant α-Interferon Treatment After Resection of Hepatocellular Carcinoma in HCV-Related Cirrhosis: a Randomized Trial on Prevention of Cancer Recurrence

Associazione Italiana per la Ricerca sul Cancro

National Cancer Institute, Milan

Skin and Connective Tissue Diseases

Exanthema

Enterovirus Infections

Picornaviridae Infections

Patients assigned to the strategy 1 will receive an invitation letter for HCV screening with DBS at the primary care center to be performed by the general practitioner

Patients assigned to the strategy 2 will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner

Patients assigned to the strategy 3 will receive an invitation letter for self-testing at home for HCV screening with DBS, and CCR screening with FOT

Patients assigned to this strategy will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner

Screening HCV attached onto CCR screening

Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT

Screening HCV attached onto CCR screening by self-testing

DBS for HCV screening at primary care center

Screening HCV at primary care center

Manuel Hernandez-Guerra, MD

The main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter offering HCV screening with dried blood spot (DBS) testing at the primary care center, b) invitation letter offering both HCV and colorectal cancer (CCR) screening with faecal occult test (FOT) at the primary care center, and c) invitation letter offering self-collected screening at home for HCV and CCR.

This is a prospective, randomized, study in which subjects of four different health areas will be invited to participate in three different screening strategies for HCV.

Hepatologists from a tertiary care hospital and general practitioners from four health areas will participate coordinating the study, to first select potential candidates for the study (subjects between 50 and 70 years old of the four areas) and secondly, randomize and include 150 subjects of each area into the three strategies (50 subjects each). The strategies include offering by letter screening at the local primary care center for HCV by using dried blood spot (DBS) testing, screening for HCV and colorectal cancer (CCR) using faecal occult test (FOT) at the primary care center, and self-testing at home-collection with DBS and FOT to be performed by the subject and sent by postal office. Subjects will receive an invitation and informative letter and will be ask to sign the informed consent to participate.

In all the planned strategies subjects will be asked to complete a questionnaire that includes demographic variables. After two months of sending the letters without response, researchers will contact subjects by phone to complete a survey to confirm they received the letter and asking for factors of non-participation.

The hypothesis of the study is that subjects in the risk of having HCV are willing to be screened for HCV infection if offered and that the acceptance will be improved if attached to CCR screening and even higher if the tests are offered to be self-screened.

For the present study, a 15% improvement in the participation (acceptance of the screening strategy) was hypothesized in the group of patients receiving the strategy 2 (and 3) compared to the strategy 1. Taking into account a power of 80%, alpha error of 5% and losses of 20% will require 200 patients per group.

Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening

Clinical Trial to Evaluate the Acceptance and Viability of Three Strategies in Birth Cohort Hepatitis C Screening

overall screening rate (number of subjects participating after enrollment)

the validity of specimens (defined as enough blood sample to fill at least one spot in the card) of DBS tests performed at primary care centers and by self-testing at home

Demographic characteristics associated with participation and feasibility of the different strategies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers	NCT04980157	Hepatitis C Vir... Colorectal Canc...	CARES-HCV	56 Years - 75 Years	H. Lee Moffitt Cancer Center and Research Institute
CARES-HCV: Promoting Screening Uptake Among Diverse Baby Boomers	NCT04980157	Hepatitis C Vir... Colorectal Canc...	CARES-HCV	56 Years - 75 Years	H. Lee Moffitt Cancer Center and Research Institute
Treatment With IFN After Curative Resection of HCC in HCV-Related Cirrhosis	NCT00273247	Hepatocellular ... Hepatitis C Vir... Liver Cirrhosis Interferon Trea... Hepatic Resecti...	Interferon alph...	18 Years - 75 Years	National Cancer Institute, Milan
Integrating Hepatitis C Screening With Dried Blood Spot Testing Into Colorectal Cancer Screening	NCT04037046	Hepatitis C Vir...	Screening HCV a... Screening HCV a... Screening HCV a...	50 Years - 70 Years	University of La Laguna

Spots Global Cancer Trial Database for hepatitis c virus infection