Prognosis Clinical Trial
— THYRONIVOOfficial title:
Thyroid Biological Toxicity and Tumor Response in Patients Treated With NIVOLUMAB 2nd Line in Non-small Cell Bronchopulmonary Cancer
Verified date | July 2020 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational, retrospective and monocentric study, conducted at the university Hospital of Brest The primary objective is to assess the association between the occurrence of thyroid dysfunction in patients treated with Nivolumab® for a non-small cell lung cancer and prognosis and therapeutic response The second objective is to assess prognosis and therapeutic response according to severity and subtype of thyroid dysfunction
Status | Completed |
Enrollment | 134 |
Est. completion date | November 5, 2019 |
Est. primary completion date | November 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients at least 18 years old and had histologically confirmed locally advanced stage (IIIB) or metastatic (IV) non-small cell lung cancer with disease progression; - treated with Nivolumab® as second or more therapeutic line - in the oncologic department university hospital of Brest - during the inclusion period between July 20, 2015 to June 30, 2018. Exclusion Criteria: - patients whose primary tumor was not from bronchopulmonary origin - patients with a history of total thyroidectomy and/or having previously treated with levothyroxine and/or having a thyroid dysfunction previously to the introduction of Nivolumab® - patients not having any thyroid monitoring during Nivolumab® treatment, and those for which data were missing - patients who expressed their opposition to participate in the study |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | OS was defined as the time between the introduction of Nivolumab® and death | up to 48 months | |
Secondary | objective response rate (ORR) | The ORR was defined as a partial or complete response | up to 48 months | |
Secondary | disease control rate (DCR) | DCR was defined as stability or as an objective response | up to 48 months | |
Secondary | Progression-free survival | PFS is defined as the time between the introduction of Nivolumab® and the date of progression or death. | up to 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101448 -
Prevalence of Bronchiectasis in COPD Patients
|
||
Recruiting |
NCT03635619 -
The Application of 3T MRI in Esophageal Cancer
|
||
Recruiting |
NCT04377854 -
Prognostic Value of BNP in MCS - a 25 Year Follow up Study
|
||
Completed |
NCT05586828 -
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
|
||
Enrolling by invitation |
NCT04517981 -
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
|
||
Recruiting |
NCT05229328 -
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
|
||
Recruiting |
NCT05848310 -
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
|
||
Completed |
NCT02582333 -
Clinical Course Study in Chronic Hepatitis B After Nucleos(t)Ide Analogue Therapy
|
||
Completed |
NCT03652402 -
Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
|
||
Recruiting |
NCT04651933 -
A Training Set for the HRD Model in EOC
|
||
Completed |
NCT04651920 -
A Study on Association Between HR Genes and the HRD Status in Chinese Epithelial Ovarian Cancer
|
||
Recruiting |
NCT03843905 -
Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.
|
||
Completed |
NCT05620537 -
A Novel Nomogram to Predict the Postoperative Overall Survival in Gastrointestinal Cancer Patients
|
||
Recruiting |
NCT03738319 -
Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer
|
||
Recruiting |
NCT03742869 -
HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
|
||
Completed |
NCT03268096 -
Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
|
||
Recruiting |
NCT04004559 -
MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)
|
||
Recruiting |
NCT05494502 -
Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients
|
N/A | |
Recruiting |
NCT04411563 -
Epigenetic Tools as Prognostic Predictors in Covid19
|
||
Not yet recruiting |
NCT04984915 -
The Usefulness of CaIMR in Patients With STEMI
|