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A 5-year Longitudinal Observational Study of the Natural History and Management of Patients With HCC

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ClinicalTrials.gov Identifier: NCT02954094
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Brief Summary:
TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

Condition or disease
Hepatocellular Cancer

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A 5-year Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma (HCC)
Study Start Date : December 2016
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024



Primary Outcome Measures :
  1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function [ Time Frame: Up to 5 years ]
  2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires [ Time Frame: Up to 5 years ]
  3. Establish a Biorepository Specimen Bank (BSB) [ Time Frame: Up to 5 years ]

Biospecimen Retention:   Samples With DNA
Patients enrolled in TARGET-HCC may be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples and tissue samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date that the sample was obtained. This link between the participant's study ID number and their name will be available only at the site where the samples were obtained.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients being managed for HCC
Criteria

Inclusion Criteria:

  1. Male or female patients, age ≥18 years
  2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

Exclusion Criteria:

1. Inability to provide written informed consent


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): NCT02954094


Contacts
Contact: Mara Grbic mgrbic@targetpharmasolutions.com

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Sponsors and Collaborators
Target PharmaSolutions, Inc.

Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT02954094     History of Changes
Other Study ID Numbers: TARGET-HCC
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type