Malignant Neoplasm of Body of Stomach in SituNCT05248763
Taiwan Cancer Moonshot Project
An observational study of Malignant Neoplasm of Body of Stomach in Situ, run by Academia Sinica, Taiwan at 1 site in Taiwan.
Trial summary
The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of Body of Stomach in Situ
- How many people
- 4,190 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2022to 31 Dec 2035
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer in Taiwan
Who may be able to join
- lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer
Who cannot join
- other cancer types
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Ming-Shiang Wu, M.D., PhD
About this study
Official title: Taiwan Cancer Moonshot Project: 1. Next-generation Pathway of Taiwan Cancer Precision Medicine (Subjective Aim 1- Taiwan Cancer Moonshot Project); 2. Development of Novel Treatments for Major Diseases (Subproject 5 - Multiomic Big Data-based Intelligent Navigation System for Precision Oncology)
The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.
Read the detailed description
Multiomic integrative analysis is an effective strategy to facilitate the investigation of molecular mechanism, cause, and early intervention of specific diseases. Gastric cancer is specifically chosen for our research target to decrease its incidence and improve survival. To increase precision diagnosis, prognosis and precision therapy, patients from Taiwan are selected as cohort subjects. The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. Genome, transcriptome, genomic methylation, proteomics, and post-translational modification will be used to construct a map for determine the in-depth carcinogenesis of gastric cancer and strategies for cancer early diagnosis, prevention, and targeted treatments.
- Keywords
- lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data
Analyze collected clinical samples by using integrated proteomics and genetics platform (genome, transcriptome, genomic methylation, proteomics, and post-translational modification)
Measured: Through study completion, an average of 2 to 3 year
Secondary outcomes (1)
Differential expressed genes and proteins in tumor
The relative difference, or fold change of expressed genes and proteins (tumors vs adjacent normal tissue)
Measured: Through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start21 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Body of Stomach in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,190 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Yu-Ju Chen, PhD, Study director, Distinguished Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248763
- Sponsor's protocol ID
- AS-IRB-BM-17056
- Status last verified
- Jul 2022
- First submitted
- 24 Jan 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Cancer Moonshot Project: 1. Next-generation Pathway of Taiwan Cancer Precision Medicine (Subjective Aim 1- Taiwan Cancer Moonshot Project); 2. Development of Novel Treatments for Major Diseases (Subproject 5 - Multiomic Big Data-based Intelligent Navigation System for Precision Oncology)
- ClinicalTrials.gov ID
- NCT05248763
- Acronym / sponsor ID
- AS-IRB-BM-17056
- Keywords
- lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,190 participants (estimated)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.
Detailed description
Multiomic integrative analysis is an effective strategy to facilitate the investigation of molecular mechanism, cause, and early intervention of specific diseases. Gastric cancer is specifically chosen for our research target to decrease its incidence and improve survival. To increase precision diagnosis, prognosis and precision therapy, patients from Taiwan are selected as cohort subjects. The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. Genome, transcriptome, genomic methylation, proteomics, and post-translational modification will be used to construct a map for determine the in-depth carcinogenesis of gastric cancer and strategies for cancer early diagnosis, prevention, and targeted treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer in Taiwan
Key inclusion criteria (1 listed)
- lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer
Key exclusion criteria (1 listed)
- other cancer types
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data
Time frame: Through study completion, an average of 2 to 3 year
Analyze collected clinical samples by using integrated proteomics and genetics platform (genome, transcriptome, genomic methylation, proteomics, and post-translational modification)
1 secondary outcome
Differential expressed genes and proteins in tumor
Time frame: Through study completion, an average of 4 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu-Ju Chen, PhD study director
Distinguished Research Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Body of Stomach in Situ, run by Academia Sinica, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ju Chen, PhD (886-2-55728660, yujuchen@gate.sinica.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data (time frame: Through study completion, an average of 2 to 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.