CClinicalTrials.gg
Sign In
Status unknownNCT02661009Updated Jan 21, 2016

Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)

An observational study in Non Small Cell Lung Cancer, EGFR-TKI Resistant Mutation and EGFR-TKI Sensitizing Mutation, sponsored by GenoSaber. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-21.

Sponsored by GenoSaber · Observational

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits.

  1. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods.
  2. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.
Read the detailed description

According to the types of samples and the purpose of the study, the research consists of two groups: plasma and tissue matching group and predicting clinical efficacy group. The samples of the plasma and tissue matching group are the same period plasma and matched FFPE(formalin-fixed paraffin-embedded tissue)samples which will be collected before the first time patients accept any anti-tumor treatment. The samples of predicting clinical efficacy group are FFPE samples which will be collected before the patients receive EGFR-TKI treatment. In addition, the subjects have the complete prognostic follow-up data.

02

Conditions studied

  • Non Small Cell Lung Cancer
  • EGFR-TKI Resistant Mutation
  • EGFR-TKI Sensitizing Mutation

Keywords

  • NSCLC
  • EGFR
  • EGFR-TKI
  • PCR
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

GenoSaber is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non Small Cell Lung Cancer(stage Ⅲ-Ⅳ)

Eligibility criteria

Plasma and tissue matching group:

Inclusion Criteria:

  • 18\~80 years old
  • Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
  • Did not receive any anti-tumor treatment.
  • Sufficient samples for analysis

Exclusion Criteria:

  • Female patients of childbearing potential who are nursing or are pregnant.
  • Samples are collected after patients receiving anti-tumor treatment.
  • The plasma sample hemolysis.
  • Tumor cells are not found in FFPE samples.
  • Incomplete information of subjects

predicting clinical efficacy group:

Inclusion Criteria:

  • 18\~80 years old
  • Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods.
  • At least one measurable focus
  • With EGFR-TKI treatment
  • Complete follow-up information after EGFR-TKI treatment
  • Sufficient samples for analysis

Exclusion Criteria:

  • FFPE samples are collected after EGFR-TKI treatment.
  • Female patients of childbearing potential who are nursing or are pregnant.
  • Tumor cells are not found in FFPE samples.
  • Incomplete information of subjects
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Plasma and tissue matching
  • predicting clinical efficacy
06

What researchers measure

Primary outcomes

  1. EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit

    Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02661009
Lead sponsor
GenoSaber
Collaborators
Shanghai Pulmonary Hospital, Shanghai, China, Sun Yat-sen University, Shanghai Chest Hospital
Responsible party
Sponsor
First posted
Jan 21, 2016
Start date
Jan 2016
Primary completion
Sep 2016 (estimated)
Last update
Jan 21, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

GenoSaber

Start the discussion