Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

Immunologic Factors

immunotherapy

Targeted Therapy Agent

Xiaomin Niu

Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Psychological distress is common and affects the efficacy and prognosis of patients with lung cancer. The systematic anti-tumor therapy may effectively relieve psychological distress including anxiety, depression, and fatigue in patients with advanced lung cancer, the relief of the psychological distress can in turn improve the therapeutic effect.

In summary, this study is to explore the associations of (dynamic) psychological stress with the efficacy and survival of anti-tumor therapy including immunotherapy and targeted therapy for advanced lung cancer patients.

Association of Psychological Distress in Patients With Lung Cancer

the Association of Psychological Distress in Patients With Advanced Lung Cancer Treated With Immunotherapy or Targeted Therapy

Collect detailed clinical information on patients with SCLC via the electronic medical records

Shanghai Chest Hospital

Principal Investigator

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Breast Carcinoma In Situ

No interventions are realized, only observational study

None intervention

A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.

Type of study:

A prospective observational longitudinal study was performed on patients who had undergone curative surgery for primary invasive breast cancer between 2010 and 2015. The study was performed in a single breast pathology unit \[Alt Penedés hospital and Sant Camil hospital(GAP)\]. Only patients with a definitive histopathology-based diagnostic of ductal carcinoma were included. Patients diagnosed with metastasis were excluded. Patients with bilateral breast cancer were included as two independent study cases.

Patients:

Sample size calculation: 191. A total of 464 patients were included in the study. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).

Data collected included clinical characteristics (age, laterality and clinical symptoms at the time of diagnostic), histopathological information (tumor size, tumor grade, hormone receptors, nodal status, HER-2 mutation (erb-b2 receptor tyrosine kinase 2), number of ki67, presence and percentage of DCIS, grade of DCIS, and surrogate subtype) and surgical procedure performed.

Tumor histopathology and the number of lymph nodes involved were evaluated by routine hematoxylin-eosin (H\&E) staining. The histological response to chemotherapy was assessed according to Miller-Payne criteria of grading (MPG) and Residual Disease in Breast and Nodes (RDBN).

The percentage of DCIS and its grade (classified as low, intermediate or high) was measured by two independent pathologists.

Statistical analysis:

Quantitative data are shown as the median or mean of values and their variability is expressed as the range or standard deviation (SD), as specified for each analysis. Qualitative data are shown as absolute values or percentages. The incidence was used as a measure of frequency and the relative risk as a measure of association between independent groups.

The study of the normality of quantitative variables was done applying the Kolmogorov-Smirnov or the Shapiro-Wilk tests, as indicated for each analysis. For significance assessment of quantitative data, unpaired Student's T-test or two-tailed Mann-Whitney U test was applied, as specified for each analysis. For significance assessment of qualitative data, Fisher's exact test or Chi-squared test was applied. For the analysis of more than two groups, one-way ANOVA and Tukey's range test for post hoc pairwise comparison of groups, or Kruskal-Wallis were used. Survival was analyzed with the Kaplan-Meier estimate and survival distributions compared with the Log-Rank test. Multivariate Cox proportional hazards regression model was used to simultaneously evaluate the effect of several factors on survival and mortality.

Statistical analysis was performed using the software SPSS® (Statistical Package for the Social Sciences) version 21.

The aim of the investigator's study is to compare the clinical and histopathological factors between patients with IDC or DCIS-associated IDC (IDC + DCIS) and find the prognostic factors associated to recurrence and mortality in each group.

Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma

Omphis Foundation

Specialists in General Surgery

A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.

Bergonie Institute Breast Cancer Database

D-DFS, distant disease-free survival, as defined following DATECAN guidelines (Gourgou et al. Annals Oncol 2015). D-DFS is defined as the time to death or appearance/occurrence of metastases/distant recurrence, whichever occurs first

Institut Bergonié

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Association of Psychological Distress in Patients With Lung Cancer	NCT06218901	Lung Neoplasms Psychological D... Prognosis Facto... Lifestyle, Heal... IMMUNOTHERAPY Targeted Molecu...	immunotherapy Targeted Therap...	18 Years -	Shanghai Chest Hospital
Association of Psychological Distress in Patients With Lung Cancer	NCT06218901	Lung Neoplasms Psychological D... Prognosis Facto... Lifestyle, Heal... IMMUNOTHERAPY Targeted Molecu...	immunotherapy Targeted Therap...	18 Years -	Shanghai Chest Hospital
Study of the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer	NCT03669952	Outcome of Brea...	None interventi...	-	Omphis Foundation
Bergonie Institute Breast Cancer Database	NCT02893761	Breast Cancer		18 Years -	Institut Bergonié
Bergonie Institute Breast Cancer Database	NCT02893761	Breast Cancer		18 Years -	Institut Bergonié
Association of Psychological Distress in Patients With Lung Cancer	NCT06218901	Lung Neoplasms Psychological D... Prognosis Facto... Lifestyle, Heal... IMMUNOTHERAPY Targeted Molecu...	immunotherapy Targeted Therap...	18 Years -	Shanghai Chest Hospital

Spots Global Cancer Trial Database for prognosis factors