Symptoms and General Pathology

All Conditions

Recurrence

Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.

No Drug

This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.

Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.

The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.

The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.

Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.

An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan

A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Bayer

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Participants with HR+/HER2-low breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

Participants with HR+/HER2-negative breast cancer who were treated with neoadjuvant chemotherapy or endocrine therapy identified from the ConcertAI databases.

This is a non-interventional study and no study drug will be provided.

No drug

There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. This retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. No study drug will be provided as part of this study protocol.

This retrospective, non-interventional study is designed to assess the following primary objectives:

1. To identify predictors of event-free survival (EFS) in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and
2. To stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as EFS, overall survival and pathological complete response across patient groups of different risk level.

Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

Identify Predictors of Clinical Outcomes in Real-world Patients With HR+ and HER2-low/Negative Breast Cancer Treated With Neoadjuvant Chemotherapy or Endocrine Therapy

Events of interest include any other primary cancer, metastases, higher stage, tumor progression, and death due to any cause.

Pathological complete response (pCR) was defined as ypT0/Tis ypN0 and is the absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy.

Daiichi Sankyo

Digestive System Diseases

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Adults using low-dose aspirin for \> 3 years

Adults using low-dose aspirin inconsistently, or consistently but \< 3 years

Subset of adult Episodic users of aspirin who discontinued the drug for at least 1 year before case/ control date

Low dose of aspirin, i.e. \< 150 mg daily

Aspirin (Acetylsalicylic Acid, BAYE4465)

The study evaluates the protective effect of low-dose aspirin use on gastrointestinal cancers (colorectal, esophageal and gastric cancers) in long-term users, episodic users and non-users of aspirin in Taiwan.

The primary objective is to investigate the protective effect of long-term low dose use of aspirin on colorectal, esophageal and gastric cancer in adult subjects from Taiwan.

Secondary objectives are to evaluate the protective effect by duration of low-dose aspirin use on colorectal cancer, the effect of discontinuation of aspirin on colorectal cancer prevention, the staging distribution of colorectal cancer and the description of fatal cases due to colorectal cancer.

Aspirin use will be identified through Taiwanese National Health Insurance (NIH) data from 2000 to 2015. Cancer cases and staging of the three cancer types will be ascertained through the Taiwan Cancer Registry, using data from 2000 to 2014. Fatal cases will be ascertained using Mortality database from 2000 to 2015.

EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan

Number of subjects with colorectal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).

Number of subjects with esophageal cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).

Number of subjects with gastric cancer for each cohort (long-term, episodic and former users of aspirin, and non-users).

The duration of low-dose aspirin use in years to colorectal cancer.

Period of time in years from discontinuation of aspirin use to detection of colorectal cancer.

The stage of cancer will be determined according to the International Classification of Diseases for Oncology (ICD-O-3).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan	NCT05793281	Advanced or Rec...	No Drug	-	Bayer
An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan	NCT05793281	Advanced or Rec...	No Drug	-	Bayer
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer	NCT06040593	Hormone-recepto... HER2-low Breast... HER2-negative B...	No drug	18 Years -	Daiichi Sankyo
EffectiveNess of Low Dose Aspirin in GastrointEstinal Cancer Prevention - Taiwan	NCT03579732	Colorectal Neop...	Aspirin (Acetyl... No drug	40 Years -	Bayer
Project Affinity: Excess Cancer Blood Testing	NCT04724005	Cancer	No drug	18 Years -	Entia Ltd
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer	NCT06040593	Hormone-recepto... HER2-low Breast... HER2-negative B...	No drug	18 Years -	Daiichi Sankyo

Spots Global Cancer Trial Database for no drug

Every month we try and update this database with for no drug cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for no drug

Every month we try and update this database with for no drug cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for no drug cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.