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| Name | Class |
|---|---|
| Beijing GeneX MedLab Co., Ltd | INDUSTRY |
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To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.
This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Participants who were diagnosed as advanced malignancy and would receive 2 cycles of personal therapy based on PTC drug screening tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing. | Diagnostic Test | Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Length is measured in millimeters, refers to RECIST 1.1. | up to 12 months |
| Partial Response (PR) | At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST.1.1. | up to 12 months |
| Progressive Disease (PD) | At least a 20% increase in the sum of diameters of taraet lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1. | up to 12 months |
| Stable Disease (SD) | Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients with malignant effusion, above 18 years of age, at Tongji Hospital, Tongji Medical College of HUST
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Huang | Contact | 63639656 | huangliu@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liu Huang | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 31564718 | Background | Leonetti A, Sharma S, Minari R, Perego P, Giovannetti E, Tiseo M. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. Br J Cancer. 2019 Oct;121(9):725-737. doi: 10.1038/s41416-019-0573-8. Epub 2019 Sep 30. |
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Malignant effusion
|
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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