NCT02300766Phase IIRecruiting
Rigshospitalet, Denmark · Medical University of Vienna, Vienna
The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS). Furthermore the purpose is to explore the clinical course and the best treatment of the syndrome.
Eligibility: to 18 Years · All · * Age \< 18 years at the date of first imaging showing this tumour
* Tumour in the cerebellum/4th ventricle/brainstem with intention to treat with surgical resection or open biopsy. Second and further surgeries are also included.
* Informed consent from custodial parent(s)
NCT07505173Phase 2Recruiting
Tianjin Medical University Cancer Institute and Hospital · Tianjin Medical University Cancer Institute and Hospital, Tianjin
This is a single-arm, multicenter, open-label, phase Ⅱ exploratory clinical study, which plans to enroll 74 treatment-naive patients with EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and symptomatic brain metastases from non-small cell lung cancer (NSCLC). The primary objective is to evaluate the intracranial progression-free survival (iPFS) of hippocampal-sparing whole-brain radiotherapy (PTV: 20Gy/10 fractions) combined with simultaneous integrated boost to brain metastases (PGTV: 40Gy/10 fractions) plus osimertinib (80mg orally once daily). The secondary objectives are to assess efficacy indicators including overall progression-free survival (PFS), intracranial/systemic objective response rate (ORR), as well as safety. The primary endpoint is iPFS, supplemented by secondary endpoints such as PFS, ORR, disease control rate (DCR), overall survival (OS), adverse events (AE) evaluated per NCI-CTCAE v5.0 criteria, and neurocognitive function scores (MMSE/HVLT-R). By optimizing the combined mode of radiotherapy and targeted therapy, this study aims to provide a safer and more effective treatment option for such patients, balancing tumor control and quality of life protection.
Eligibility: 18 Years to 75 Years · All · * Signed a written informed consent form prior to enrollment;
* Aged 18-75 years;
* Histopathologically confirmed non-small cell lung adenocarcinoma (NSCLC); EGFR gene test confirmed EGFR sensitive mutations, including exon 19 deletion (19del) and exon 21 L858R mutation (verified and confirmed by investigators at the respective study centers);
* Brain metastasis confirmed by contrast-enhanced cranial CT/MRI; the number of brain metastatic lesions requiring local dose escalation is 1-10, with at least one measurable intracranial lesion having a diameter ≥10 mm; the distance between metastatic lesions and important cerebral functional areas meets radiotherapy-related requirements; at least one measurable lesion (per RECIST v1.1 criteria) confirmed by contrast-enhanced extracranial CT/PET-CT;
* Symptomatic brain metastasis;
* ECOG performance status score: 0-2;
* Expected survival time of no less than 12 weeks;
* No prior anti-tumor treatment received for NSCLC;
* Normal function of vital organs, meeting the following requirements (no blood components or cell growth factors administered within 14 days):
A) Routine blood test criteria: Hb ≥100 g/L; ANC ≥1.5×10⁹/L; PLT ≥75×10⁹/L; B) Biochemical test criteria: TBIL ≤1.5×ULN (upper limit of normal); ALT and AST ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN); serum creatinine ≤1.5×ULN, creatinine clearance rate ≥50 ml/min (calculated based on the Cockroft-Gault formula); C) Coagulation function criteria: INR ≤1.5×ULN and APTT ≤1.5×ULN; D) Cardiac color Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%;
\- For non-surgically sterilized patients or women of childbearing potential: a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment period and for 3 months after the end of study treatment; non-surgically sterilized women of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment, and must not be breastfeeding.
All subjects voluntarily participate in the study, with good compliance and willingness to cooperate with safety and overall survival follow-up.
NCT04073966Phase IIRecruiting
UNC Lineberger Comprehensive Cancer Center · University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill, North Carolina
Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.
Eligibility: 18 Years to · All · * Histologic diagnosis of cancer
* Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.
* Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.
* Anticipated life expectancy at least 1 year
* Age ≥ 18 years
* Ability to read and comprehend written English and follow instructions in English
* Ability to provide informed consent
NCT07339930Phase IIRecruiting
University Hospital, Strasbourg, France · ervice d'Endocrinologie, Diabétologie et Nutrition - CHU de Strasbourg - France, Strasbourg
Polycystic ovary syndrome (PCOS) is the leading endocrine disorder of the reproductive system, affecting 10 to 13% of women of childbearing age. However, there is a significant delay in diagnosis, which may be due to considerable clinical heterogeneity and a lack of information among the general population. The diagnosis is made when two of the three Rotterdam criteria established in 2003 and revised in 2023 are met, namely: 1) menstrual cycle disorders (oligoanovulation) - 2) clinical or biological hyperandrogenism - 3) OPK morphological appearance or elevated anti-Müllerian hormone (AMH) levels, after exclusion of differential diagnoses. PCOS is a condition that carries a risk of metabolic complications and fertility problems due to dysovulation. Patients have an impaired quality of life and are at greater risk of anxiety and depression, which should be screened for systematically.
Eligibility: 18 Years to 49 Years · All · * Adult woman (≥18 years and \<50 years)
* Subject who consulted at the Strasbourg University Hospitals for suspected PCOS or for any other endocrinological condition that led to the discovery of PCOS.
NCT06851429Phase IIRecruiting
Chang Gung Memorial Hospital · Chang Gung Memorial Hospital, Taoyuan City, Guishan District
Ovarian cancer remains the deadliest gynecologic malignancy, with poor survival rates largely due to late-stage diagnosis. Early detection is crucial, yet no universally accepted screening method exists. Current imaging techniques and biomarkers, such as CA-125, have limitations in specificity and sensitivity. This study aims to develop and evaluate a deep learning-based computer-aided diagnosis tool (CAT-OV), for ovarian cancer detection using CT imaging. The system integrates a Body Part Regression (BPR) model for pelvic localization and a Multiple Instance Learning (MIL) ensemble classifier for cancer prediction. The model was trained and validated using retrospective datasets from Taiwan, the United States, and a nationwide real-world cohort. Stringent preprocessing and quality control measures were implemented to enhance model accuracy. Results highlight the potential of AI-driven CT screening in improving early detection, though further validation is needed for clinical adoption.
Eligibility: 20 Years to · Female · 1. Age ≥ 20 years old.
2. Female
3. undergone a CT scan
4. undergone a CT scan within 180 days prior to ovarian surgery for histopathological evaluation.
NCT06277531Phase IIRecruiting
Peking University Third Hospital · Peking University Third Hospital, Beijing, Beijing Municipality
Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.
Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.
In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.
Eligibility: 18 Years to 85 Years · All · * Patients is suspected indetermined biliary strictures
* Patients have the indication for ERCP
NCT07684131Phase IIRecruiting
Versailles Hospital · Groupe hospitalier sud, Amiens
An observatory for patients aged 18 years and over with Philadelphia chromosome positive (Ph+ or BCR::ABL1) acute lymphoblastic leukemia (ALL) and treated with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticosteroids and/or a monoclonal antibody.
Eligibility: 18 Years to · All · 1. Male or female patients ≥ 18 years
2. Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia
3. Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody
NCT07782944NARecruiting
Guilin Medical University, China · The First Affliated Hospital of Guilin Medical University, Guilin, Guangxi
The objective of the study is to construct a noninvasive approach CD38 targeted PET/CT to detect tumor lesions in patients with Multiple Myeloma and to compare with FDG PET/CT.
Eligibility: 18 Years to · All · * Adult patients (aged 18 years or older);
* Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of Multiple Myeloma (supporting evidence may include MRI, CT, tumor markers, and pathology report);
* Patients who had scheduled both standard-of-care imaging (FDG PET/CT) and cd38 PET/CT scans;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
NCT05518851Phase IIRecruiting
Peking University First Hospital · Peking University Third Hospital, Beijing, Beijing Municipality
In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.
Eligibility: 18 Years and older · All · * Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
* Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.
NCT06733987Phase IIRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna · IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna
This is a single-centre, observational, prospective and exploratory study, which involves the use of human tissues from patients affected by Relapsed/Refractory classic Hodgkin Lymphoma treated with pembrolizumab at the Departmental Diagnosis and Therapy program for chronic lymphoproliferative syndromes of the IRCCS AOU of Bologna. Peripheral blood samples will be used for the study and will be taken:
* before starting treatment with pembrolizumab.
* undergoing therapy with pembrolizumab (cycle 2 (C2), C3, C4, C8, C12).
Eligibility: 18 Years to · All · * Patients of both sexes aged ≥ 18 years at enrollment
* Patients affected by cHL R/R candidate to receive a treatment with Pembrolizumab
* Signature of informed consent
NCT04028531Phase IIRecruiting
Dana-Farber Cancer Institute · Dana Farber Cancer Institute, Boston, Massachusetts
The purpose of this study is to collect human Chronic Lymphocytic Leukemia tissue samples and medical information, in order to find out more about the causes and biology of chronic lymphocytic leukemia.
Eligibility: 18 Years to · All · * New and existing patients seen for treatment of monoclonal B-cell lymphocytosis
* Any low grade lymphoproliferative disorder
* Chronic Lymphocytic Leukemia in the Dana Farber Cancer Institute Hematologic Oncology Clinic or elsewhere
NCT07684131Phase IIRecruiting
Versailles Hospital · Groupe hospitalier sud, Amiens
An observatory for patients aged 18 years and over with Philadelphia chromosome positive (Ph+ or BCR::ABL1) acute lymphoblastic leukemia (ALL) and treated with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticosteroids and/or a monoclonal antibody.
Eligibility: 18 Years to · All · 1. Male or female patients ≥ 18 years
2. Philadelphia chromosome or BCR::ABL1 positive acute lymphoblastic leukaemia
3. Treatment with the combination of BCR::ABL1 inhibitors and chemotherapy and/or corticotherapy and/or a monoclonal antibody
