ClinicalTrials.gg
RecruitingNCT03253107Updated Oct 4, 2023

Predicting Biomarker of Gastric Cancer Chemotherapy Response

An observational study in Gastric Cancer, Chemotherapy Effect and Predictive Cancer Model, sponsored by Kyungpook National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Kyungpook National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2015; still recruiting 10 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
800
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 521 studies in Stomach Neoplasms with a site in Korea, Republic of — 78 open to participants now, 116 under way, 20 of them phase 3. Stomach Neoplasms · Korea, Republic of.

Planned enrollment
25th of 71
800 · median 444
Started
2015
with 28 others
Observational
71 of 521
7 open now
Primary completion
2024-12
later than 14 of 115 live
Registered
286th of 521
by date

Among the 521 studies in Stomach Neoplasms with a site in Korea, Republic of, this one is the 25th largest by planned enrollment of the 71 observational ones that give a count, is one of 29 that started in 2015, is one of 71 observational ones, reaches primary completion later than 14 of the 115 other live ones, and was the 286th registered.

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

78 of the 521 studies in Stomach Neoplasms with a site in Korea, Republic of are open now. Recruiting first, the newest first:

73 more — sign in →

All 78 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.

This study: 20 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 521 studies in Stomach Neoplasms with a site in Korea, Republic of, or all of them as a file.
02

Study summary

  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

    • Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
    • Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
    • Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
  • Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response
Read the detailed description
  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

    • Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)

      • institutional primary Chemotherapy regimen (XP or Xelox)

        1. response group
        2. progression group

          Post-OP adjuvant chemotherapy

      • institutional primary Chemotherapy regimen

        1. complete response group
        2. non-responder group

        <!-- -->

        1. and 2) groups: age, sex, regimen matched
    • Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group

      • the same patients in mRNA sequencing
    • Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
  • Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer
03

Conditions studied

  • Gastric Cancer
  • Chemotherapy Effect
  • Predictive Cancer Model

Browse trials for

Keywords

  • gastric cancer
  • RNA sequencing
  • chemotherapy response
  • miRNA sequencing
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

\<Next generation sequencing analysis> (A) palliative chemotherapy

  1. responder (n=15)
  2. progression (n=15)

(B) adjuvant chemotherpay

  1. complete response (n=15)
  2. non-responder (n=15)

\<qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy

  1. responder (n=60)
  2. progression (n=60)

(B) adjuvant chemotherpay

  1. complete responder (n=60)
  2. non-responder (n=60)

(Validation set) (A) palliative chemotherapy

  1. responder (n=40)
  2. progression (n=40)

(B) adjuvant chemotherpay

  1. complete responder (n=40)
  2. non-responder (n=40)
  1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
  • patients who agreed this study and voluntarily assigned the informed consents.

Exclusion criteria

Exclusion Criteria:

  • patients who refused the study.
  • patients who have other cancers
  • heavy alcoholics
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • responder in palliative chemotherapy

    After initial chemotherapy, responder (complete remission, partial remission)

    Drug: Chemotherapy

  • non-responder in palliative chemotherapy

    After initial chemotherapy, disease progression

    Drug: Chemotherapy

  • responder in adjuvant chemotherapy

    complete cure and no recurrence at least 1 year after treatment

    Drug: Chemotherapy

  • non-responder in adjuvant chemotherapy

    non-complete cure or recurrence within 1 year after treatment

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

    Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin

    Also known as: XP or Xelox +/- Herceptin

06

What researchers measure

Primary outcomes

  1. Discovery of predicting bio-markers for gastric cancer chemotherapy response

    Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR

    Time frame: up to 36 months

Secondary outcomes

  1. Combination prediction model for adjuvant chemotherapy response in gastric cancer

    Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer

    Time frame: up to 5 years

  2. Combination prediction model for palliative chemotherapy response in gastric cancer

    Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2015 (actual). Primary completion is estimated for Dec 2024, 109 months after the start.

Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's planned 109 months is above that.

Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2017
First posted
Aug 17, 2017
StartActual
Nov 30, 2015
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Oct 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03253107
Lead sponsor
Kyungpook National University Hospital
Responsible party
Su Youn Nam (Professor, Kyungpook National University Chilgok Hospital) — Principal investigator
First posted
Aug 17, 2017
Start date
Nov 30, 2015
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 4, 2023

Study contacts

Su Youn Nam, MD, PhD
Contact
nam20131114@gmail.com
82-53-200-2610
Su Youn Nam, MD, PhD
principal investigator · Kyungpook National University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion