Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated ProteomicsNCT04525209
Integrative Proteomic Characterization of Pancreatic Ductal Adenocarcinoma
An observational study of Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated Proteomics, run by Ruijin Hospital at 1 site in China.
Trial summary
A large-scale, high-throughput, multi-dimensional comprehensive study of PDAC multiomics will be carried out. In this study, clinical specimens of resected PDAC collected by our research group from 2017 to 2019 will be selected as research objects.Tumor tissues and their adjacent non-tumor tissues from more than 200… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated Proteomics
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese PDAC patients
Who may be able to join
- The diagnosis of pancreatic cancer was confirmed by histological examination or fine needle aspiration cytology;
- The tumor was graded according to THE WHO standard, and the tumor stage was graded according to the TNM stage;
Who cannot join
- The inclusion criteria of the above groups were not met;
- There are few tissue specimens, only enough for clinical diagnosis;
- Patients are unwilling to conduct follow-up study;
- For the new diagnosed patient, radiotherapy or chemotherapy have been given in the previous three months;
Trial locations and contacts
1 site in 1 country.
China1 site
RUIJIN Hospital
Shanghai, Shanghai Municipality, 200025
Jian Li, Ph.D
About this study
A large-scale, high-throughput, multi-dimensional comprehensive study of PDAC multiomics will be carried out. In this study, clinical specimens of resected PDAC collected by our research group from 2017 to 2019 will be selected as research objects.Tumor tissues and their adjacent non-tumor tissues from more than 200 PDAC patients are expected to be used for genome, transcriptome sequencing and mass spectrometry analysis of proteome and phosphorylated proteome.Combined with the data results of multiomics, bioinformatics analysis and network database information, we will clarify the relationship between multiomics of pancreatic cancer and established the new subtyping of pancreatic cancer proteome. A molecular landscape of the progression of pancreatic cancer at the genome-transcriptome-proteome level provides new therapeutic targets to improve the prognosis of this deadly disease.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrative Proteomic Characterization of PDAC
The genome-transcriptome proteome level provides a molecular landscape of the progression of pancreatic cancer, providing new therapeutic targets to improve the prognosis of PDAC
Measured: Two yeaers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated ProteomicsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAOCHEN, Ruijin Hospital
- Investigators
- Hao Chen, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525209
- Sponsor's protocol ID
- 2020-08-20
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao Q, Zhu H, Dong L, Shi W, Chen R, Song Z, Huang C, Li J, Dong X, Zhou Y, Liu Q, Ma L, Wang X, Zhou J, Liu Y, Boja E, Robles AI, Ma W, Wang P, Li Y, Ding L, Wen B, Zhang B, Rodriguez H, Gao D, Zhou H, Fan J. Integrated Proteogenomic Characterization of HBV-Related Hepatocellular Carcinoma. Cell. 2019 Oct 3;179(2):561-577.e22. doi: 10.1016/j.cell.2019.08.052.
PubMed 31585088Cancer Genome Atlas Research Network. Electronic address: andrew_aguirre@dfci.harvard.edu; Cancer Genome Atlas Research Network. Integrated Genomic Characterization of Pancreatic Ductal Adenocarcinoma. Cancer Cell. 2017 Aug 14;32(2):185-203.e13. doi: 10.1016/j.ccell.2017.07.007.
PubMed 28810144
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Proteomic Characterization of Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04525209
- Acronym / sponsor ID
- 2020-08-20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Aug 2020 (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.
A large-scale, high-throughput, multi-dimensional comprehensive study of PDAC multiomics will be carried out. In this study, clinical specimens of resected PDAC collected by our research group from 2017 to 2019 will be selected as research objects.Tumor tissues and their adjacent non-tumor tissues from more than 200 PDAC patients are expected to be used for genome, transcriptome sequencing and mass spectrometry analysis of proteome and phosphorylated proteome.Combined with the data results of multiomics, bioinformatics analysis and network database information, we will clarify the relationship between multiomics of pancreatic cancer and established the new subtyping of pancreatic cancer proteome. A molecular landscape of the progression of pancreatic cancer at the genome-transcriptome-proteome level provides new therapeutic targets to improve the prognosis of this deadly disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese PDAC patients
Key inclusion criteria (2 listed)
- The diagnosis of pancreatic cancer was confirmed by histological examination or fine needle aspiration cytology;
- The tumor was graded according to THE WHO standard, and the tumor stage was graded according to the TNM stage;
Key exclusion criteria (4 listed)
- The inclusion criteria of the above groups were not met;
- There are few tissue specimens, only enough for clinical diagnosis;
- Patients are unwilling to conduct follow-up study;
- For the new diagnosed patient, radiotherapy or chemotherapy have been given in the previous three months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Integrative Proteomic Characterization of PDAC
Time frame: Two yeaers
The genome-transcriptome proteome level provides a molecular landscape of the progression of pancreatic cancer, providing new therapeutic targets to improve the prognosis of PDAC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Background: PubMed 31585088Gao Q, Zhu H, Dong L, Shi W, Chen R, Song Z, Huang C, Li J, Dong X, Zhou Y, Liu Q, Ma L, Wang X, Zhou J, Liu Y, Boja E, Robles AI, Ma W, Wang P, Li Y, Ding L, Wen B, Zhang B, Rodriguez H, Gao D, Zhou H, Fan J. Integrated Proteogenomic Characterization of HBV-Related Hepatocellular Carcinoma. Cell. 2019 Oct 3;179(2):561-577.e22. doi: 10.1016/j.cell.2019.08.052.
- Results publication: PubMed 28810144Cancer Genome Atlas Research Network. Electronic address: andrew_aguirre@dfci.harvard.edu; Cancer Genome Atlas Research Network. Integrated Genomic Characterization of Pancreatic Ductal Adenocarcinoma. Cancer Cell. 2017 Aug 14;32(2):185-203.e13. doi: 10.1016/j.ccell.2017.07.007.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Hao Chen, MD principal investigator
Ruijin Hospital
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 Tumor Tissues and Non-tumor Tissues From PDAC Patients Were Used for Genomic and Transcriptome Sequencing Analysis and Proteomics and Phosphorylated Proteomics, run by Ruijin Hospital at 1 site in China.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen, MD (13003135899, haochendr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrative Proteomic Characterization of PDAC (time frame: Two yeaers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525209, which also lists 2 linked publications.
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 25 Aug 2020.