Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Blood samples collection: at Day (D)-6 and D0 before CAR-T cells injection, post injection at Day (D)3, D5,D7, D9, D11, D14, D18, D 21, Month 2 and Month 12 post injection.

Blood sample collection

Dominique GENRE, MD

Jihane PAKRADOUNI, Pharm PhD

GENRE Dominique, MD

Claude Lemarié, PharmD

In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed

Immunological Profile for Patients Treated With CAR-T Cells

Serum concentration of cytokines in relation to adverse events

Relapse rate from CAR-T cells infusion to one year

Cytokine release syndrome from CAR-T cells infusion to one year

Institut Paoli-Calmettes

Symptoms and General Pathology

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Inflammation

Neoplasm Metastasis

Adrenal Insufficiency

Addison Disease

Neoplastic Processes

Adrenal Gland Diseases

Endocrine System Diseases

Autoimmune Diseases

Addison's Disease

Secondary Adrenal Insufficiency

Anti-Inflammatory Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Dermatologic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Epinephrine

Glucocorticoids

Cortisone

Racepinephrine

Epinephryl borate

Hydrocortisone-17-butyrate

Hormones

Hormone Antagonists

Plenadren (modified release hydrocortison) 20-25 or 30 mg oral tablets will be administered once-daily at 8.00 AM in the fasting state The dose is kept the same as patients had before entering the trial.

Hydrocortisone (dose range 10 to 30) mg will be continued as before entering the study. Cortisone Acetate (dose 25 to 37.5 mg) will be continued as before entering the study. The morning dose will be administered in the fasting state.

The total daily dose and timing is not changed during the study period.

Healthy volunteers will be enrolled as control group

Plenadren

Conventional glucocorticoid therapy

Andrea M Isidori, MD, PhD

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.

In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.

Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

A Randomized, Controlled, Multi-Centre Trial on the Effects of Dual-release Hydrocortisone Preparations Versus Conventional Glucocorticoid Replacement Therapy in Patients Affected by Primary and Secondary Adrenal Insufficiency. DREAM Trial.

Single outcome measurement of body weight (kg).

Composite outcome measure consisting of simultaneous measurment of: Glycaemia, Insulinemia, Homa index, Glycated Haemoglobin, Total Cholesterol, LDL cholesterol, HDL cholesterol, Triglyceredes; the composite outcome measured at 3 and 6 months.

Composite outcome measure consisting of simultaneous measurment of: Full Count Blood Cell, ESR, Fibrinogen, Immunoglobulin, PCR; measured at baseline, 3 and 6 months.

Composite outcome measure consisting of simultaneous measurment of: serum calcium, phosphate, parathyroid hormone (PTH), 25OH-vitamin D, phosphate, osteocalcin, bone phosphate alkaline (sBALP), serum-cross-linked N and C-telopeptide of bone type I collagen (NTx- CTx); measure at baseline and 6 months.

Measurement of epicardial fat thickness (EFT) by hihg-resolution M-B-mode transthoracic echocardiography from baseline at 6 months.

Evaluation of hepatic steatosis by conventional ultrasound of the liver and with ASQ software with dedicated equipment and 7-5 Mhz convex probe frome baseline at 6 months.

Quality of life will be measured by questionnaires: AddiQol, Middle Sex Hospital Questionnaire (MHQ), International Index of Erectile Function (IIEF), Female Sexual Function Index (FSFI), Beck Depression Inventory Test (BDI-II).

Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)

University of Roma La Sapienza

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct)

Intervention : Collection of two blood samples (5mL)

* before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
* and then, after chemotherapy (post-CT), up to 3 months after enrollment

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct) Collection of two blood samples (5mL),
* before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
* and then, after chemotherapy (post-CT), up to 3 months after enrollment

Marie Vanseymortier

Delphine Hudry, MD

Fabrice Narducci, MD

Cyril Abdeddaim, MD

Annick Chevalier, MD

Eric Leblanc, MD

Emilie Kaczmarek, MD

Alfred Bassil, MD

Charlotte Bellier, MD

This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct)

Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.

The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.

Other objectives of the study include:

* Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)
* Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)
* Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic
* Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy
* Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy

For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint

For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint

To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)

In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion

Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy

Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause

Time between diagnosis and death, whatever the cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunological Profile for Patients Treated With CAR-T Cells	NCT05054231	Hematologic Neo...	Blood sample co...	18 Years -	Institut Paoli-Calmettes
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)	NCT02277587	Primary Adrenal... Secondary Adren...	Plenadren Conventional gl...	18 Years - 80 Years	University of Roma La Sapienza
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)	NCT02277587	Primary Adrenal... Secondary Adren...	Plenadren Conventional gl...	18 Years - 80 Years	University of Roma La Sapienza
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer	NCT03922776	Ovarian Cancer ... Fallopian Tube ... Fallopian Tube ... Ovarian Cancer ...	Blood sample co...	18 Years -	Centre Oscar Lambret

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