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This study aims to investigate the prognostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) radiomics in diffuse large B-cell lymphoma (DLBCL) and its additional value to the International Prognostic Index (IPI).
Several studies have shown that 18F-FDG PET radiomics is predictive of survival in DLBCL. However, to the best of the investigator's knowledge, a multi-feature radiomic signature for prognosis assessment of DLBCL has not yet been described. Furthermore, it remains unclear whether PET-based radiomics could add more prognostic values to the IPI in DLBCL.
This study aims to develop 18F-FDG PET radiomic signature, and investigate whether the radiomic signature could improve the prognostic value of the IPI score in predicting progression-free survival (PFS) and overall survival (OS) in DLBCL.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET radiomic feature evaluation | Other | A total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features. In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | the period from the initial diagnosis to the death from any cause | From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years |
| Progression-free Survival | the period from the initial diagnosis to the progression, relapse or death from any cause | From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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The target study population of this retrospective study is patients with DLBCL who have undergone pre-treatment 18F-FDG PET/CT prior to the R-CHOP or R-EPOCH chemotherapy. The study will assess the relationships between PET-derived radiomic features with the patient outcome data.
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| Name | Affiliation | Role |
|---|---|---|
| Mei Tian, M.D. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34651227 | Derived | Zhang X, Chen L, Jiang H, He X, Feng L, Ni M, Ma M, Wang J, Zhang T, Wu S, Zhou R, Jin C, Zhang K, Qian W, Chen Z, Zhuo C, Zhang H, Tian M. A novel analytic approach for outcome prediction in diffuse large B-cell lymphoma by [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1298-1310. doi: 10.1007/s00259-021-05572-0. Epub 2021 Oct 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Training Cohort | Patients diagnosed between July 2013 and March 2017. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg). |
| FG001 | Validation Cohort | Patients diagnosed between April 2017 and July 2019. All patients underwent pre-treatment 18F-FDG PET/CT. PET/CT images were acquired on a Biograph mCT scanner (Siemens Healthcare, Germany) 60-70 min after intravenous injection of 18F-FDG (3.7 MBq/kg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Training Cohort | Patients diagnosed between July 2013 and March 2017 |
| BG001 | Validation Cohort | Patients diagnosed between April 2017 and July 2019 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | the period from the initial diagnosis to the death from any cause | Posted | Median | Full Range | months | From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years |
|
|
From patient diagnosis to the end of the study, up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training Cohort | Patients diagnosed between July 2013 and March 2017 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaohui Zhang | Second Affiliated Hospital, School of Medicine, Zhejiang University | +86-571-87767188 | zhanghui4127@zju.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2021 | Aug 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| lactate dehydrogenase | Normal: 190-245 U/L; Elevated: > 245 U/L | Count of Participants | Participants |
|
| β2-microglobulin | Normal: 1.0 - 3.0 μg/L; Elevated: > 3.0 μg/L | Count of Participants | Participants |
|
| Ann Arbor stage | Ann Arbor stage was evaluated based on the Lugano classification. Stage I: only one node or a group of adjacent nodes involved. Stage II: two or more nodal groups on the same side of the diaphragm. Stage III: nodes on both sides of the diaphragm, or nodes above the diaphragm with spleen involvement. Stage IV: additional noncontiguous extralymphatic involvement. Stage I/II were classified as limited stage (with better prognosis), while stage III/IV were defined as advanced stage (with worse prognosis). | Count of Participants | Participants |
|
| Performance status | Performance status was evaluated according to the Eastern Cooperative Oncology Group (ECOG) criteria. Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Score 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; Score 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Score 4: Completely disabled. | Count of Participants | Participants |
|
| B symptoms | The B symptoms were defined as the occurrence of one or more of three symptoms: weight loss (>10% over 6 months), heavy night sweats and fever (>38°C). | Count of Participants | Participants |
|
| Extranodal sites | Extranodal sites included the bone marrow, gastrointestinal tract, liver, lung, central nervous system, and other sites. The numbers of extranodal disease sites were recorded as 0, 1, or more than 1. | Count of Participants | Participants |
|
| International Prognostic Index | The International Prognostic Index was defined according to the number of the following risk factors: elevated LDH, age >60 years, ECOG performance score ≥2, involvement of more than one extranodal site, and Ann Arbor stage III/IV. Score 0/1: Low risk; Score 2: Low-intermediate risk; Score 3: High-intermediate risk; Score 4: High risk | Count of Participants | Participants |
|
| Cell of origin | Count of Participants | Participants |
|
| Treatment | Count of Participants | Participants |
|
| Chemotherapy regimens |
| Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Progression-free Survival | the period from the initial diagnosis to the progression, relapse or death from any cause | Posted | Median | Full Range | months | From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years |
|
|
|
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Validation Cohort | Patients diagnosed between April 2017 and July 2019 | 14 | 52 | 0 | 52 | 0 | 52 |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Chemotherapy + autologous stem cell transplantation |
|