Clinical trials: sponsored by IRCCS San Raffaele
Healthy Population
Italian Digital Primary Cardiovascular Prevention Study
The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular…
- Trial name
- CV-PREVITAL (NCT05339841)
- Testing
- Mobile health application
- Where
- 32 sites in Italy
- Volunteers
- 27,520 people, healthy volunteers welcome
- Sponsor
- Centro Cardiologico Monzino
Malignant Tumor, Benign Neoplasm
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
This retrospective observational study aims to evaluate the efficacy and toxicity of advanced radiotherapy (ART) techniques, including intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and stereotactic…
- Conditions
- Malignant Tumor, Benign Neoplasm, Parkinson Disease, Trigeminal Neuralgia
- Trial name
- 25-ART-HSR (NCT07894900)
- Testing
- Advanced radiotherapy techniques
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- IRCCS San Raffaele
Tumor Burden, Neuroendocrine (NE) Tumors
Multicenter Study for External Validation of the TB-NET Score
This is a retrospective, observational, multicenter study aiming to externally validate the TB-NET Score in an independent cohort of patients with advanced well-differentiated gastroenteropancreatic neuroendocrine tumors…
- Trial name
- TB-NET (NCT07903532)
- Where
- 11 sites in United States, Brazil and 7 more
- Volunteers
- 400 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Glioblastoma
Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)
This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2).
- Trial name
- NCT06551909
- Testing
- Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Esophageal Cancer, Colorectal (Colon or Rectal) Cancer
Quantitative Fluorescence Angiography With ICG for Perfusion Assessment During Surgery
The accurate assessment of intraoperative tissue perfusion is essential in any branch of surgery. Anastomotic leakage (AL) is one of the most feared complications following gastrointestinal surgery, with potentially threatening…
- Trial name
- SPY Q-ICG PAS (NCT05489757)
- Testing
- SPY Portable Handheld Imaging (SPY-PHI) System with SPY-QP Software
- Where
- Italy
- Volunteers
- 196 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
Advanced Radiotherapy (ART) in Prostate Cancer (PROST-ART)
This is a retrospective monoinstitutional study which analyses the results of advanced radiotherapy (IGRT, IMRT, SBRT, and PET-guided) performed for radical, adjuvant, or salvage purposes in patients with low, intermediate, high…
- Trial name
- PROST-ART (NCT06546267)
- Testing
- Image Guided Radiotherapy, Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy
- Where
- Italy
- Volunteers
- 2,500 people
- Sponsor
- IRCCS San Raffaele
Neurologic Ambulation Disorder
Interactive Intensive Gait Training in Walking Limitations
Gait-MAP is a prospective, randomized, single-blind clinical trial designed to evaluate the effectiveness of an Intensive Interactive Gait Training (IIGT) program in adults with neurological conditions associated with pyramidal…
- Trial name
- Gait-MAP (NCT07899528)
- Testing
- Intensive Interactive Gait Training, Conventional Gait Rehabilitation
- Where
- Italy
- Volunteers
- 112 people
- Sponsor
- IRCCS San Raffaele Roma
Renal Cancer, Renal Secondary Cancer
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
This is a prospective, interventional, monocentric, clinical study of Stereotactic Body Radiation Therapy (SBRT) for primary or secondary renal tumors, delivering from 25-26 Gy/1 fraction to 42-48 Gy/3-4 fractions or 40-50 Gy/5…
- Conditions
- Renal Cancer, Renal Secondary Cancer, Stereotactic Body Radiotherapy
- Trial name
- SBRTRC (NCT07285538)
- Testing
- Stereotactic body radiotherapy (SBRT)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- IRCCS San Raffaele
Oligometastatic Disease
Ablative Radiosurgery vs Stereotactic RT in 5 Fractions With SIB for Oligometastatic Bone Lesions
This is a randomised prospective monoinstitutional study comparing radiosurgery at a total dose up to 24 Gy to five fraction stereotactic radiotherapy with simultaneous integrated boost (SIB) up to 50 Gy for the treatment of bone…
- Trial name
- ONES (NCT05679427)
- Testing
- radiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively
- Where
- Italy
- Volunteers
- 307 people
- Sponsor
- IRCCS San Raffaele
Localized Prostate Carcinoma
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission…
- Trial name
- PRO-FAST (NCT05936736)
- Testing
- prostate SBRT
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- IRCCS San Raffaele
Parkinson's Disease
Telerehabilitation in People With Parkinson's Disease
Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are…
- Trial name
- TEMPO (NCT05773885)
- Testing
- VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy), Conventional rehabilitation
- Where
- 2 sites in Italy
- Volunteers
- 58 people
- Sponsor
- IRCCS San Raffaele Roma
Breast Cancer, Quality of Life
Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience
This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast…
- Conditions
- Breast Cancer, Quality of Life, Radiotherapy; Adverse Effect, Dermatitis or Eczema, Survivorship
- Trial name
- Ipomammella (NCT03077191)
- Testing
- Quality of life measurement
- Where
- Italy
- Volunteers
- 410 people
- Sponsor
- IRCCS San Raffaele
Breast Cancer
5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
This is a prospective, randomized, single-center, non-inferiority interventional clinical trial comparing whole breast irradiation (WBI) to a total dose of 26 Gy in 5 fractions with simultaneous integrated boost (SIB) to the…
- Trial name
- NCT07020780
- Testing
- Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- IRCCS San Raffaele
Gynecologic Cancer, Radiotherapy Side Effect
Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART)
This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy…
- Conditions
- Gynecologic Cancer, Radiotherapy Side Effect, Radiotherapy; Complications, Survivorship
- Trial name
- GYN-ART (NCT06306170)
- Testing
- Image Guided Radiotherapy
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- IRCCS San Raffaele
Breast Cancer
Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)
This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable…
- Trial name
- Breast-1F (NCT06946238)
- Testing
- Adjuvant single-fraction accelerated partial breast irradiation
- Where
- Italy
- Volunteers
- 311 people
- Sponsor
- IRCCS San Raffaele
Acute Myeloid Leukemia
Harnessing the Immunosuppressive Leukemic Microenvironment to Engineer T Cells With Enhanced Anti-tumor Functionality
This is a monocentric, retrospective and prospective study aimed to underline the potential of T-cell receptor (TCR)-mediated Ab recognition from the post transplant setting in acute myeloid leukemia (AML).
- Trial name
- SynT (NCT07743047)
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Spinal Cord Injuries (SCI), Muscle Spasticity as a Result of Spinal Cord Injury
Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury
Spinal Cord Injury (SCI) represents a significant health challenge, particularly when it comes to the ability to walk. Among its many consequences, mobility impairment can not only directly impact quality of life but also cause a…
- Conditions
- Spinal Cord Injuries (SCI), Muscle Spasticity as a Result of Spinal Cord Injury, Rehabilitation, Exoskeleton Device
- Trial name
- EKSO-SCI (NCT07884591)
- Testing
- Wearable Powered Exoskeleton
- Where
- Italy
- Volunteers
- 74 people
- Sponsor
- IRCCS San Raffaele Roma
Migraine Disorders
(Italian Migraine Registry, I-GRAINE-NEW)
Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic "evolutionary" condition.
- Trial name
- I-GRAINE-NEW (NCT07163416)
- Where
- Italy
- Volunteers
- 2,030 people
- Sponsor
- IRCCS San Raffaele Roma
Healthy, Parkinson Disease
Motion Capture in Box and Bloks Test
This study aims not only to develop a standardized protocol for performing the targeted BBT but also to assess synchronized parameters: kinematic (using IMUs) and electrophysiological (EMG) data.
- Conditions
- Healthy, Parkinson Disease, Stroke, Upper Extremity Paresis
- Trial name
- BBT_MOCAP (NCT07883174)
- Testing
- Inertial Measurement Unit and Box and Block test
- Where
- Italy
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele Roma
HSCT
Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy
This prospective and retrospective, observational, monocentric study aims to investigate the longitudinal dynamics, phenotype, and functional properties of regulatory T cells (Tregs) in patients affected by hematological…
- Trial name
- OSR_ReCARmune (NCT07883330)
- Where
- Italy
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Ciceri Fabio