Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Sorafenib

Patients with transarterial chemoembolization (TACE) will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.

Patients with Sorafenib treatment will get an "Image Fingerprint" and "Molecular Fingerprint" for tumor characterization in vivo.

This is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics

Image Fingerprint

This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing

Molecular Fingerprint

Michael Bitzer, MD

This single center, open-label, uncontrolled, non-randomized observational study in patients with advanced HCC. The patients qualify either to a local treatment with transarterial chemoembolization (TACE) or to a systemic treatment with the multikinase inhibitor sorafenib. The aim of this feasibility study is to get a comprehensive image and molecular fingerprint of individual tumors, with the intention to govern therapy decisions. Furthermore, to improve the care of patients that get progressive disease under treatment, the investigators have to improve the investigators understanding of the development of therapy resistance, which will improve patient care at the time point of progressive disease. Therefore, the data of 20 patients in each group will be used to identify molecular and / or image patterns, that can be used to predict treatment responses and thus govern an optimized individual cancer treatment for patients with advanced HCC.

A single-center, open-label, uncontrolled, non-randomized clinical trial. The two treatment groups to receive:

Group A Transarterial Chemoembolization (TACE): 20 patients that are treated with TACE will get an image and molecular fingerprint of the tumor prior to the first treatment with TACE, a second image fingerprint between week 2 - 4 after the first treatment with TACE, and a third image and molecular fingerprint at the time point of progressive disease.

Group B Sorafenib: 20 patients that are treated with Sorafenib will get an image and molecular fingerprint of the tumor prior to the first treatment, between week 2 and 3 after the start of treatment and at the time point of progressive disease.

Biospecimens that will be investigated are tumor tissue and blood.

Fingerprint Characterization of Advanced HCC

Fingerprint Characterization of Advanced HCC to Optimize Treatment Decisions and Enable an Early Prediction of Therapy Resistance (HCC Multiscale Trial-1)

The aim of this feasibility study is to get comprehensive image and molecular fingerprints of individual tumors that can be used for systems biology approaches to predict therapy outcome and govern therapeutic decisions.

To set-up and optimize the workflow of data gathering and analysis for molecular and image fingerprints.

Correlation of results from image and molecular fingerprints at one point of time

Correlation of either image or molecular fingerprints at three different time points

To identify molecular and image patterns of early treatment failure.

To identify molecular and image patterns of early treatment success

To compare molecular and image patterns from HCC patients with respective patterns from different animal models which might identify suitable preclinical models for different clinical tumor patterns.

To determine ideal imaging methods for an early prediction of progressive disease

To set up a molecular diagnostic board that checks for data-based tailored treatment options

To identify clinical relevant biomarkers from tumor tissue or blood / urine analysis

German Federal Ministry of Education and Research

University Hospital Tuebingen

Deputy Director Department of Gastroenterology

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Quality of Life

Carl AK Borrebaeck, Professor

This study aims to define the association between psychological resilience and biomolecular signatures in cancer patients and to relate psychological resilience to prognosis, as this could potentially open up a novel avenue of therapeutic interventions, medical as well as psychosocial.

Individual patients differ in psychological response when receiving a cancer diagnosis. Given the same disease burden some patients master the situation well and others do experience a great deal of stress, depression and lowered quality of life. A patient's mental resistance after acquiring a threat, like a cancer diagnosis, called psychological resilience, is known to impact the outcome of the disease. Patients with high psychological resilience are likely to experience less stress reactions, and a better adaptation and management of the life threat and the demanding therapeutic interventions. How this phenomenon of mastering difficult situations is reflected also in bio-molecular processes is not much studied and how these have an impact on the cancer prognosis and the effectiveness of treatment is today not fully understood. However, there is evidence that expressing the emotions evoked is an important part of fighting cancer.

Our hypothesis is that patients displaying a high psychological resilience, according to a standardized method "The Connor-Davidson resilience scale" i.e. low stress reactions, low hopelessness and low fatigue, also present a specific pattern of biomolecular signatures in blood, represented by its epigenome, microRNA and proteomic patterns.

This project specifically aims to investigate if breast cancer patient´s psychological resilience can be coupled to bio-molecular parameters, using advanced "omics" and as a secondary aim, if it relates to prognosis and quality of life one year after diagnosis.

The study includes only women with newly diagnosed breast cancer

Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience

The Molecular Fingerprint of Psychological Resilience - Implications for Diagnostic and Therapeutic Strategies

Upon publication, the relevant anonymized individual participant data will be shared.

Measured by CD-RISC and bimolecular techniques.

Measured by CD-RISC and study specific questionnaire based on the Swedish national cancer rehabilitation guidelines.

Measured by CD-RISC correlated to register data

Measured by CD-RISC and correlated to register data

Measured by SF-36 and correlated to register data

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fingerprint Characterization of Advanced HCC	NCT02372162	Carcinoma, Hepa...	Image Fingerpri... Molecular Finge...	18 Years -	University Hospital Tuebingen
Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience	NCT03430492	Breast Cancer		18 Years -	Lund University
Fingerprint Characterization of Advanced HCC	NCT02372162	Carcinoma, Hepa...	Image Fingerpri... Molecular Finge...	18 Years -	University Hospital Tuebingen

Spots Global Cancer Trial Database for molecular fingerprint