Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Liver Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients with Hepatocellular Carcinoma (HCC)

Physician's choice according to patient's needs.

iOMEDICO AG

Thomas Berg, Prof.Dr.

Peter R. Galle, Prof.Dr.

Wolf P. Hofmann, Prof.Dr.

Achim Kautz

Philippe Pereira, Prof.Dr.

Karin Potthoff, Dr.

Jan Schröder, PD Dr.

Robert Thimme, Prof.Dr.

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany.

JADE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of HCC or CCC in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with HCC / CCC will be evaluated for up to three years.

Liver Cancer Registry Platform

JADE - Clinical Research Platform on Treatment and Outcome in Patients With Hepatocellular or Cholangiocellular Cancer

Documentation of anamnestic data and therapy sequences.

Documentation of response rates per line of treatment.

Documentation of progression-free survival per line of treatment.

Documentation of overall survival per line of treatment.

EORTC QLQ-C30 core questionnaire \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems\]

EORTC QLQ-HCC18, the hepatocellular carcinoma specific module / EORTC QLQ-BIL21, the cholangiocarcinoma specific module \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems\].

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Nicolas Graf, PD Dr.

Frank Kullmann, Prof. Dr.

Marlies Michl, PD Dr.

Jens Neumann, Prof. Dr.

Roland Schnell, PD Dr.

Sebastian Stintzing, Prof. Dr.

The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.

AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

Registry Platform Colorectal Cancer

Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)

EORTC QLQ-C30 core questionnaire \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems\].

EORTC QLQ-CR29 \[European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems\].

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):

* with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or
* with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.

Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Thomas Decker, Prof.Dr.

Ingolf Juhasz-Böss, Prof.Dr.

Elmar Stickeler, Prof.Dr.

Dirk Watermann, Prof.Dr.

Anja Welt, Dr.

Achim Wöckel, Prof.Dr.

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.

The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

All patients will be asked to give additional informed consent agreeing that their routinely collected tumor samples could be used for further translational research. For the decentralized biobank, pathological samples will remain with the local pathologist until scientific translational question arise. Future translational research projects that will develop during the project will be described in detail in independent research proposal and reviewed by an ethics committee.

Registry Platform Ovarian and Endometrial Cancer

SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale

Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liver Cancer Registry Platform	NCT04510740	Hepatocellular ... Cholangiocarcin...	Physician's cho...	18 Years -	iOMEDICO AG
Registry Platform Colorectal Cancer	NCT04867525	Colorectal Canc...	Physician's cho...	18 Years -	iOMEDICO AG
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Registry Platform Ovarian and Endometrial Cancer	NCT05129969	Ovarian Cancer Endometrial Can... Ovary Neoplasm Endometrial Neo... Carcinoma, Ovar... Carcinoma Neoplasm, Ovari...	Physician's cho...	18 Years -	iOMEDICO AG
Liver Cancer Registry Platform	NCT04510740	Hepatocellular ... Cholangiocarcin...	Physician's cho...	18 Years -	iOMEDICO AG

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