Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS

Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS - Screening of draggable mutations in cytological samples obtained from lung cancer patients using a highly sensitive, multigene test, MINtS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040415

Enrollment

500

Registered

2020-05-20

Start date

2021-11-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are equal to or more than 20 years old when the informed consent is obtained. 2) Patient who are suspected of having lung cancer or who are suspected of having an exacerbating or relapsed disease by imaging studies. 3) Patients from whom both cytological and tissue samples are obtained and cancer cells are detected in either cytological sample or tissue sample. 4) Patients from whom informed consent is obtained.

Exclusion criteria

Exclusion criteria: Pattens who do not fulfill the inclusion criteria.

Design outcomes

Primary

Measure	Time frame
The detection rate of draggable mutations from cytological samples when the concomitantly isolated tissue samples contain cancer cells.	—

Secondary

Measure	Time frame
(1) The rate that amenable DNA is isolated. (2) The rate that amenable RNA is isolated. (3) The rate that MINtS is successfully performed. (4) The number of patients who are positive for cancer in cytological samples and positive for cancer in tissue samples. (5) The number of patients who are negative for cancer in cytological samples and positive for cancer in tissue samples. (6) The number of patients who are positive for cancer in cytological samples and negative for cancer in tissue samples. (7) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and positive for cancer in tissue samples. (8) Detection rate of draggable mutations in patients who are negative for cancer in cytological samples and positive for cancer in tissue samples. (9) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and negative for cancer in tissue samples. (10) The rate that the sample is submitted to the companion diagnostics already approved in Japan when tissue sample is positive for cancer cells. (11) The concordance rate between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples. (12) The difference of prices between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples. (13) The overall response rate defined by the doctor in charge in patients who are positive for draggable mutations detected either by the companion diagnostics already approved in Japan or by MINtS.	—

Measure

Time frame

(1) The rate that amenable DNA is isolated. (2) The rate that amenable RNA is isolated. (3) The rate that MINtS is successfully performed. (4) The number of patients who are positive for cancer in cytological samples and positive for cancer in tissue samples. (5) The number of patients who are negative for cancer in cytological samples and positive for cancer in tissue samples. (6) The number of patients who are positive for cancer in cytological samples and negative for cancer in tissue samples. (7) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and positive for cancer in tissue samples. (8) Detection rate of draggable mutations in patients who are negative for cancer in cytological samples and positive for cancer in tissue samples. (9) Detection rate of draggable mutations in patients who are positive for cancer in cytological samples and negative for cancer in tissue samples. (10) The rate that the sample is submitted to the companion diagnostics already approved in Japan when tissue sample is positive for cancer cells. (11) The concordance rate between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples. (12) The difference of prices between MINtS and the companion diagnostics already approved in Japan when when the samples is positive for both cytological samples and tissue samples. (13) The overall response rate defined by the doctor in charge in patients who are positive for draggable mutations detected either by the companion diagnostics already approved in Japan or by MINtS.

—

Countries

Japan

Contacts

Public ContactWataru Yamasaki

Non-profit organization North East Japan Study Group Office

nejsg-dm@nejsg.jp048-778-9521

Outcome results