Assessment of tumor proportion for biomarker tests prior to the selection of first-line therapy in advanced non-squamous non-small cell lung cancer patients in the real world setting in Japan: a prospective, multicenter, observational study

JRCT ID: jRCT1030210622

Registered date:19/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 09/03/2022
• Target sample size: 240
• Study type: Observational

Outcome(s)

• Primary Outcome: The agreement in assessment of tumor cell proportion between Local pathologist and Central Pathology Committee

Secondary Outcome

1. The agreement in assessment of tumor cell proportion between Machine learning algorithm and other raters (vs. Local pathologist, vs. Central Pathology Committee)
ICC
Bland-Altman analysis
2. Distribution of categories based on differences in tumor cell proportion assessment value between raters by grade (none/ mild, moderate, severe) of each pathological finding (Inflammatory cells, Fibrosis, Mucous, Necrosis, Crush)
The categories will be following
Underestimation, Complete agreement, Overestimation
Non/ slight, Moderate, Considerable
Both raters (A and B) <30percent, Rater A < 30percent and Rater B >= 30percent, Rater A >= 30percent and Rater B < 30percent, Both raters (A and B) >= 30percent

Diagnosis performance regarding tumor cell proportion between raters dichotomized based on the cut-off values of 10, 20 and 30percent using assessment by Central Pathology Committee as the gold standard the concordance rate, sensitivity, specificity, positive predictive value, negative predictive value, and The Cohen kappa coefficient

3. Success rate of ODxTT and AmoyDx Pan Lung Cancer PCR Panel
1)Success rate in ODxTT and AmoyDx Pan Lung Cancer PCR Panel
2)Success rate of each biomarker in ODxTT and AmoyDx Pan Lung Cancer PCR Panel
3)ODxTT and AmoyDx Pan Lung Cancer PCR Panel success rate by sample condition
4)Sample conditions by success or unsuccess of ODxTT and AmoyDx Pan Lung Cancer PCR Panel
4. Testing results of each biomarker measured by ODxTT and other methods
5. Categories of 1st line treatment regimens

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patient aged at least 20 years at the time of consent.
2.Pathologically confirmed non-squamous NSCLC.
3.Newly diagnosed, locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology), not amenable to curative surgery or radiotherapy
4.Treatment- naive for locally advanced/ metastatic/ recurrent NSCLC
5.Tumor cell proportion was assessed using FFPE samples and biomarker test was ordered within the period between diagnosis of locally advanced/ metastatic/ recurrent NSCLC and starting 1st line treatment.
6.Provision of informed consent prior to the start of 1st line therapy and any study specific procedures.

• Exclude criteria: None

Related Information

• Primary Sponsor: Hiroshi Kitagawa