EvaluationNCT06142058
RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for NSCLC
An observational study of Evaluation and NSCLC, run by Xueqin Yang at 1 site in China.
Trial summary
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation, NSCLC, Targeted Therapy
- What is being tested?
- RecistTM criteria
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: NSCLC patients with stage IIIB-IV，Driver gene positive， and any one of the tumor markers is more than three times higher than the normal level,
Who may be able to join
- NSCLC patients with stage IIIB-IV
- Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);
- First line targeted therapy.
- Performance status of 0-2 on the ECOG criteria.
- Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA>15ng/ml,CA-199>105U/ml,CA-125>105 U/ml, NSE>60 ng/ml, SCCAg>7.5 ng/ml, CYFRA21-1>21 ng/ml, et al.
- Measurable lesions present
Show all 9Show fewer
- Age>=18
- Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 60,000/uL,hemoglobin≥70g/L), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function.
- Informed consent from patient or patient's relative.
Who cannot join
- Patients with dysphagia;
- Unable to taking medication on time;
- Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Center, Dapping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality, 400042
Xueqin Yang, PH.D., 86-23-68757151, yangxueqin@hotmail.com
Xueqin Yang, PH.D.
About this study
Official title: Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.
Read the detailed description
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.
- Conditions
- Evaluation, NSCLC, Targeted Therapy
- Being tested
- RecistTM criteria
- Keywords
- tumor marker, NSCLC, RECIST, RecistTM, positive driving gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecistTM criteriaDiagnostic test
Also called RECIST criteria
RecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation consistency
The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.
Measured: efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year
Secondary outcomes (1)
progression-free survival （PFS）
The correlation between the efficacy evaluation results of the RecistTM criteria and the RECIST criteria and PFS
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start13 Nov 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xueqin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xueqin Yang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142058
- Sponsor's protocol ID
- RecistTM-1
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the RecistTM Criteria in Evaluating the Efficacy of Targeted Therapy for Advanced Non-small Cell Lung Cancer With Positive Driving Genes
- ClinicalTrials.gov ID
- NCT06142058
- Acronym / sponsor ID
- RecistTM-1
- Conditions
- Evaluation, NSCLC, Targeted Therapy
- Keywords
- tumor marker, NSCLC, RECIST, RecistTM, positive driving gene
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Xueqin YangUniversity, hospital or other
- Study start
- 13 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Nov 2023 (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.
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the prelimary criteria still need further improvement. Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes.
Detailed description
Investigators established the efficacy evaluation criteria for tumor markers (RecistTM) in the preliminary research. The establishment of this criteria makes the application of tumor markers in clinical efficacy evaluation more objective and solves the problem of consistency in clinical efficacy evaluation. Among patients with advanced non-small cell lung cancer, patients with positive driving genes are more likely to exhibit abnormalities in tumor markers, which suggests that this criteria may be more suitable for evaluating the efficacy of targeted therapy in driving gene positive patients. Moreover, The judgment rules of the preliminary criteria still need further improvement. . Therefore, in order to broaden the application scope of the RecistTM criteria, further improve the evaluation rules of RecistTM criteria, and multi-dimensionally confirm the reliability of RecistTM criteria on efficacy evaluation, investigators plan to conduct research on the application of RecistTM criteria in evaluating the efficacy of targeted therapy for advanced non-small cell lung cancer with positive driving genes. Investigators used statistical analysis to assess the consistency of efficacy evaluation between the RecistTM criteria and the RECIST criteria, the correlation between different efficacy and progression free survival (PFS) under the RecistTM, and the correlation between the efficacy of RecistTM criteria and ctDNA level.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients with stage IIIB-IV，Driver gene positive， and any one of the tumor markers is more than three times higher than the normal level,
Key inclusion criteria (9 listed)
- NSCLC patients with stage IIIB-IV
- Driver gene positive (EGFR,ALK,C-MET, ROS,RET, HER2);
- First line targeted therapy.
- Performance status of 0-2 on the ECOG criteria.
- Any one of the tumor markers is more than three times higher than the normal level, and the tumor markers include: CEA>15ng/ml,CA-199>105U/ml,CA-125>105 U/ml, NSE>60 ng/ml, SCCAg>7.5 ng/ml, CYFRA21-1>21 ng/ml, et al.
Key exclusion criteria (3 listed)
- Patients with dysphagia;
- Unable to taking medication on time;
- Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
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 |
|---|---|---|
| RecistTM criteriaAlso: RECIST criteriaRecistTM criteria and RECIST criteria were used to evaluate the efficacy of targeted therapy for NSCLC with positive driving gene. | Diagnostic test | – |
Primary outcome
Evaluation consistency
Time frame: efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year
The ratio of the number of patients with the same efficacy evaluated both by RecistTM and Recist criteria to the total number of the patients.
1 secondary outcome
progression-free survival （PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Related trials for Evaluation
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
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.
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 Evaluation and NSCLC, run by Xueqin Yang 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 9 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: looking for participants now, as of the sponsor's last update on 21 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqin Yang, PhD (15923366936, yangxueqin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation consistency (time frame: efficacy evaluation at the 1st, 3rd, 6th month after treatment, and every 3 months thereafter up to 1 year). 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 21 Nov 2023.