Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Neoplastic Processes

Hematinics

All Drugs and Chemicals

Liver Extracts

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach

stereotactic radiation therapy (SRT)

Fiorenza De Rose, MD

Tiziana Comito, MD

Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer

Istituto Clinico Humanitas

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

Herbal and Botanical

Fluorouracil

Cola

Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.

Collection of tumour samples from samples collected as part of standard patient management. Diagnostic pathological analysis will be a priority. These samples will be taken by experienced staff during the hospital visit scheduled as part of standard care.

Scheduled and planned surgery

Philippe CASSIER, MD

Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.

This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.

Tumour samples collected for this study include:

* A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.
* A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.

* A fragment of the previously operated primary tumor: block and/or archived frozen tumor if available.
* A fragment of the liver metastasis.

Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer

Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer

Rate of incorporation of 5-fluorouracil into ribosomes of tumor tissues and adjacent healthy tissues before surgery and after surgery.

Analyze on a large scale the alterations of the 2'-O-methylation profile of ribosomal RNAs before surgery and after surgery

Define a transcriptomic and proteomic profile of the collected samples before surgery and after surgery.

Combination of the number of 5-fluorouracil molecules incorporated per rRNA molecule, the methylation profile and the transcriptomic profile before surgery and after surgery.

Centre Leon Berard

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Neoplastic Cells, Circulating

Metastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data

Gastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial

Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment

A blood sample will be collected once, prior to treatment.

Blood Draw

Andrew Z Wang, MD

The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.

This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).

Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes

LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes

To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)

To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)

UNC Lineberger Comprehensive Cancer Center

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Klatskin Tumor

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Bile Duct Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Fibrolamellar Carcinoma

Participants' cases are discussed in tumor conference without the use of ADBoard, according to conventional practice.

Participants' cases will be evaluated by ADBoard directly before they are discussed in the tumor conference.

Utilizing the clinical decision support system 'ADBoard' for therapy selection in participants with hepatobiliary tumors

ADBoard

Felix Krenzien

Christian Benzing

The goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'ADBoard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. The main questions it aims to answer are:

Can ADBoard achieve a high level of similar recommendations as physicians' tumor conferences? Can ADBoard consider a more complete set of patient-related data than in physicians' tumor conferences? Can ADBoard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? Participants will have their hepatobiliary tumor treatments determined by either tumor conference with ADBoard, or tumor conference without ADBoard.

The ADBoard study is a monocentric, prospective, parallel randomized controlled trial with a non-inferiority framework. Participants will be randomized 1:1 into one of two groups: either a) tumor conference with ADBoard, or b) tumor conference without ADBoard.

Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards

Evaluation of the Trustworthiness of the Application of Artificial Intelligence and Decision Support Systems for the Creation of Tumor Conference Protocols

Examples of possible treatment recommendations are liver resection (curative), regimen of chemotherapy, immunotherapy, radiotherapy, transarterial chemoembolisation, diagnostics, best-supportive care, follow-up by re-presentation.

The interrater reliability of the recommendations of ADBoard and the tumor conferences with regard to their agreement will be measured.

The intrarater reliability will be measured by testing all participant cases several times by the ADBoard according to the required sample size with sufficient statistical power (test-retest). Interrater and intrarater reliability will be evaluated descriptively (percentage of agreement, contingency tables), and finally the Cohen-Kappa value will be assessed.

For each type of tumor examined, a series of relevant parameters is defined by the medical staff. The objective is achieved if complete documentation, defined as documentation status 'present' or 'detected as missing', is present in more than or equal to 75% of all ADBoard-assisted decisions.

The System Causability Scale will be reviewed by 3 specialist physicians. The score ranges from 0 to 1. A higher score means greater suitability of the user interface, explanation, or explanation process itself for the intended purpose of tumor conference treatment recommendations.

The time between the initial presentation of the case to the tumor conference and the time of recommendation implementation will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas
Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer	NCT04274790	Cancer of Colon Metastasis to L...	Scheduled and p...	18 Years -	Centre Leon Berard
Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes	NCT04280640	Cancer Metastasis Lung Metastasis to L... Circulating Tum... Gastrointestina... Bladder Cancer	Blood Draw	18 Years -	UNC Lineberger Comprehensive Cancer Center
Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes	NCT04280640	Cancer Metastasis Lung Metastasis to L... Circulating Tum... Gastrointestina... Bladder Cancer	Blood Draw	18 Years -	UNC Lineberger Comprehensive Cancer Center
Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer	NCT04274790	Cancer of Colon Metastasis to L...	Scheduled and p...	18 Years -	Centre Leon Berard
Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes	NCT04280640	Cancer Metastasis Lung Metastasis to L... Circulating Tum... Gastrointestina... Bladder Cancer	Blood Draw	18 Years -	UNC Lineberger Comprehensive Cancer Center
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards	NCT05681949	Hepatocellular ... Fibrolamellar H... Cholangiocarcin... Intrahepatic Ch... Metastasis to L... Gallbladder Car...	ADBoard	18 Years -	Charite University, Berlin, Germany
Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards	NCT05681949	Hepatocellular ... Fibrolamellar H... Cholangiocarcin... Intrahepatic Ch... Metastasis to L... Gallbladder Car...	ADBoard	18 Years -	Charite University, Berlin, Germany
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for metastasis to liver