Esophageal CancerNCT03081988
Prediction Model of Response for CCRT in Esophageal Cancer
An observational study of Esophageal Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
1. Retrospective review of old patients Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 2. Prospective case-control study: RNA sequencing \& miRNA microarray naive esophageal cancer patients who have a plan to receive concomitant… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- chemoradiotherapy
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2015to 31 Dec 2024
- How long will I take part?
- 3 Years
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
Who may be able to join
- locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
- persons who assigned the written informed consents.
Who cannot join
- persons who did't assign the informed consents
- other organ cancer
- heavy alcoholics
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Medical Canter
Daegu, 41404
Su Youn Y Nam, MD, PhD, 82-53-200-2610, nam20131114@gmail.com
About this study
Official title: Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology
- Retrospective review of old patients
- Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015
Read more
- Prospective case-control study: RNA sequencing \& miRNA microarray
- naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy
- acquirement of tissue, blood, clinical information
- isolation of RNA, DNA, serum database of clinical \& demographic information *Analysis of mRNA sequencing / miRNA sequencing** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
- Experimental set for qPCR (esophageal tissue) study group
- TMA for screened exon gene
- validation set for qPCR (esophageal tissue)
- follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
- Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors
- Validate the prediction model.
Read the detailed description
- Retrospective review of old patients
- Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 Study Group
- non responder
- CR but recurrence
- CR and survival loner than 2 years
- Prospective case-control study: RNA sequencing \& miRNA microarray
- naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy --> acquirement of tissue, blood, clinical information --> isolation of RNA, DNA, serum database of clinical \& demographic information study group
- non-responder (N=14)
- Complete Remission (N=14) For considering the drop rate, 2-fold screening *Analysis of mRNA sequencing / miRNA sequencing** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
- Experimental set for qPCR (esophageal tissue) study group
- non-responder (N=40)
- complete remission (N=40)
- TMA for screened exon gene
- validation set for qPCR (esophageal tissue) new esophageal cancer set
- non-responder (N=30)
- complete remission (N=30)
- follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
- Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors Test several combination models
- gene + gene combination,
- gene + clinical information combination,
- gene + gene + clinical information combination
- Validate the prediction model.
- primary organoid culture and prediction of chemoradiotherapy response
- Conditions
- Esophageal Cancer
- Being tested
- chemoradiotherapy
- Keywords
- Esophageal Cancer, chemoradiotherapy response, molecular factors
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiotherapyOther
concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.
| Study group | Role | What they receive |
|---|---|---|
| Responder | Complete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer
evaluation of disease status: endoscopy, CT, and/or PET-CT Receives: Other: chemoradiotherapy | |
| non-responder | Progressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer
evaluation of disease status: endoscopy, CT, and/or PET-CT Receives: Other: chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction model for CCRT response based on clinical and genetic molecular factors
prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer
Measured: up to 36 months
Secondary outcomes (4)
banking of remained human material for post genetic & molecular study
banking of remained human material for post genetic \& molecular study
Measured: up to 10 years
circulating preditction marker for CCRT response and prognosis
circulating miRNA sequencing
Measured: up to 5 years
tissue prediction marker for CCRT response and prognosis
tissue RNA sequencing / tissue microarray
Measured: up to 5 years
in-vitro prediction of CCRT using primary esophageal cancer organoid
- Esophageal cancer derived primary organoid culture
- treat RT and 5-FU to esophageal cancer organoid
- measure the response of CCRT (live cell/dead cell)
- This process is in-vitro process, not in-vivo experiment.
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start19 Oct 2015
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- 140 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Youn Nam, Kyungpook National University Hospital
- Investigators
- Su Youn Nam, MD, PhD, Principal investigator, Kyungpook National University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081988
- Sponsor's protocol ID
- 2015R1D1A1A01059219
- Status last verified
- Oct 2023
- First submitted
- 18 Feb 2017
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology
- ClinicalTrials.gov ID
- NCT03081988
- Acronym / sponsor ID
- 2015R1D1A1A01059219
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, chemoradiotherapy response, molecular factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Mar 2017 (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.
- Retrospective review of old patients
- Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015
- Prospective case-control study: RNA sequencing \& miRNA microarray
- naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy
- acquirement of tissue, blood, clinical information
- isolation of RNA, DNA, serum database of clinical \& demographic information *Analysis of mRNA sequencing / miRNA sequencing** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
- Experimental set for qPCR (esophageal tissue) study group
- TMA for screened exon gene
- validation set for qPCR (esophageal tissue)
- follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
- Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors
- Validate the prediction model.
Detailed description
- Retrospective review of old patients
- Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015 Study Group
- non responder
- CR but recurrence
- CR and survival loner than 2 years
- Prospective case-control study: RNA sequencing \& miRNA microarray
- naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy --> acquirement of tissue, blood, clinical information --> isolation of RNA, DNA, serum database of clinical \& demographic information study group
- non-responder (N=14)
- Complete Remission (N=14) For considering the drop rate, 2-fold screening *Analysis of mRNA sequencing / miRNA sequencing** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator
- Experimental set for qPCR (esophageal tissue) study group
- non-responder (N=40)
- complete remission (N=40)
- TMA for screened exon gene
- validation set for qPCR (esophageal tissue) new esophageal cancer set
- non-responder (N=30)
- complete remission (N=30)
- follow-up of circulating miRNA in blood (baseline blood \& post-CCRT blood 3M, 6M, 12M)
- Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors Test several combination models
- gene + gene combination,
- gene + clinical information combination,
- gene + gene + clinical information combination
- Validate the prediction model.
- primary organoid culture and prediction of chemoradiotherapy response
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder | – | Other: chemoradiotherapyComplete Remission after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT |
| non-responder | – | Other: chemoradiotherapyProgressive disease or stationary state after chemoradiotherapy in locally advanced or advanced esophageal cancer evaluation of disease status: endoscopy, CT, and/or PET-CT |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
Key inclusion criteria (2 listed)
- locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
- persons who assigned the written informed consents.
Key exclusion criteria (3 listed)
- persons who did't assign the informed consents
- other organ cancer
- heavy alcoholics
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 |
|---|---|---|
| chemoradiotherapyconcomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research. | Other | Responder, non-responder |
Primary outcome
Prediction model for CCRT response based on clinical and genetic molecular factors
Time frame: up to 36 months
prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer
4 secondary outcomes
banking of remained human material for post genetic & molecular study
Time frame: up to 10 years
circulating preditction marker for CCRT response and prognosis
Time frame: up to 5 years
tissue prediction marker for CCRT response and prognosis
Time frame: up to 5 years
in-vitro prediction of CCRT using primary esophageal cancer organoid
Time frame: up to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Su Youn Nam, MD, PhD principal investigator
Kyungpook National University Medical Center
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 Esophageal Cancer, run by Kyungpook National University Hospital at 1 site in South Korea.
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 3 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 4 Oct 2023. 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 South Korea. 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 Su Youn Y Nam, MD, PhD (82-53-200-2610, nam20131114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction model for CCRT response based on clinical and genetic molecular factors (time frame: up to 36 months). 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 4 Oct 2023.