[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"second-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:second-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100505013","phase-2-preventing-second-cancers-with-dostarlimab-100505013",false,"NCT05855811","PREventing Second Cancers With DOSTARlimab","A Multicenter, Open-label, Randomized Phase II Study Aiming to Assess the Clinical Impact of Dostarlimab on Occurrence of Second Primary Cancer in Patients With Cured Primary Cancer","PREDOSTAR","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature. Note - Patients with childhood first primary cancer (FPC) are eligible.\n* Patients with prior histologically proven primary solid tumors (any type), AJCC stage I, II or III or IV if M0, eligible to curative treatment. Note - Time between end of treatment for first cancer and randomisation must be \\\u003C6 months.\n* Patients with at least one risk factor for second primary cancer (SPC) including:\n* Exposure to exogenous risk factor : tobacco (\\>20YP) ≥ 10 years and still active at time of FPC diagnosis and\u002For Endogenous risk factors (genetic predisposition including for instance germ line mutations of p53 or BRCA genes, Lynch syndrome, or any mutations of genes known to be associated with higher risk of cancer according to current list from French National Cancer institute or HPV-related FPC.\n* Availability of FFPE tumor sample from FPC initial diagnosis for histological comparison in case\u002Fat time of SPC. Note - Histological report must be sent to the sponsor with archival FFPE tumor block within 14 days after randomisation.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or .\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n* WBC ≥ 2.5 x 109\u002FL,\n* Hemoglobin ≥ 9.0 g\u002FdL. Patients may be transfused (\\> 2 weeks before randomisation) to meet this criterion,\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL without granulocyte colony-stimulating factor support within 2 weeks before randomisation,\n* Platelets ≥ 100 x 109\u002FL,\n* Lymphocyte count ≥ 0.5 x 109\u002FL;\n* Serum creatinine clearance ≥30 mL\u002Fmin\u002F1.73m2 (MDRD or CKD-EPI formula - See Appendix) or serum creatinine ≤1.5 ULN\n* Serum bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled;\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN;\n* Prothrombin time\u002FINR ≤ 1.5, or, if patient is receiving therapeutic anticoagulation, prothrombin time\u002FINR \\\u003C 3.0\n* aPTT ≤ ULN OR, if patient is receiving therapeutic anticoagulation, aPTT must be \\\u003C 1.5 ULN. Note: Patient receiving therapeutic anticoagulation must be on stable dose.\n* Proteinuria by urine dipstick \\\u003C 2+ or 24-hour proteinuria ≤ 1.0 g.\n* Corrected QT interval (QTc) \\\u003C450msec (or QTc \\\u003C480msec for participants with bundle branch block).\n* Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy and agrees to use adequate contraception for up to 6 months after the final dose of dostarlimab.\n* Fertile men must agree to use an effective method of contraception during the study and for up to 6 months after the last dose of dostarlimab.\n* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n* Patients must be covered by a medical insurance in country where applicable.\n\nExclusion Criteria:\n\n* Previous treatment with immunotherapy (any types) for cured first primary cancer.\n* Acute and ongoing toxicities from previous therapy that have not resolved to Grade ≤ 1, except for alopecia, neuropathy and lab values presented in inclusion criteria.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to randomisation or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to randomisation, or anticipation of need for systemic immunosuppressive medication during study treatment; with the exceptions of intranasal, inhaled, or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n* Systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation.\n* Oral or IV antibiotics within 14 days of randomisation.\n* History of severe allergic or other hypersensitivity reactions to:\n\n  * chimeric or humanized antibodies or fusion proteins,\n  * biopharmaceuticals produced in Chinese hamster ovary cells, or\n  * any component of the dostarlimab formulation\n* Concurrent treatment with any approved or investigational anti-cancer treatment or participation in another clinical trial with therapeutic intent. Note - Hormonotherapy as part of standard of care is allowed.\n* History of autoimmune disease including (see Appendix 18.5 for a more comprehensive list of pre-existing autoimmune diseases and immune deficiencies and exceptions in the protocol.\n* Infectious diseases:\n\n  * active infection requiring IV antibiotics,\n  * severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n  * active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening),\n  * active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,\n  * HIV infection,\n  * active tuberculosis,\n  * influenza vaccination should be given during influenza season. Patients must not receive live attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to randomisation or at any time during the study.\n* Significant cardiovascular disease: see details in the protocol.\n* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan.\n* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).\n* Patient with FPC known to be at high risk of relapse defined as ≥ 70% relapse from FPC within 2 years.\n* Patient patients who are solid organ recipients.\n* Patient with primary cancer of unknown origin (CUP).\n* Pregnant or lactating women","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive:\n\n* Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or\n* Arm No treatment",[27,28,29],"Recurrent Cancer","Primary Cancer","Second Cancer","RECRUITING","2024-07-12",{"date":33,"type":34},"2024-07-15","ACTUAL",{"date":36,"type":34},"2023-07-26",{"date":38,"type":21},"2029-03-26",{"name":40,"class":41},"Centre Leon Berard","OTHER",5,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100414888","the-prospective-observational-compraya-cohort-study-100414888","NCT04682470","The Prospective Observational COMPRAYA Cohort Study","COMPRehensive Assessment of Prevalence, Risk Factors and Mechanisms of Impaired Medical and Psychosocial Health Outcomes Among Adolescents and Young Adults With Cancer: the Prospective Observational COMPRAYA Cohort Study","COMPRAYA","Inclusion Criteria:\n\n* Pathological confirmed cancer diagnosis;\n* Age 18 - 39 years at time of first cancer diagnosis;\n* Able to understand the informed consent form;\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Mentally incompetent patients based on the opinion of treating physician .\n* Inability to understand the Dutch language\n* Life expectancy less than 6 months based on the opinion of treating physician .","39 Years",{"count":53,"type":21},4000,"10 Years","OBSERVATIONAL","Rationale: Childhood cancer survivorship attracts attention globally, because successes in treatment have led to increasing number of survivors who reach adulthood, in which survivorship issues affecting health-related quality of life (HRQoL) become prominent. Most paediatric patients are treated intensively with irradiation and\u002For chemotherapy, which put them at risk for early and\u002For late adverse medical and psychosocial events. In contrast, much less is known about adolescent and young adult (AYA) cancer patients, diagnosed between 18-39 years, who, with an 80% chance to survive, also have a long life ahead. AYA cancer patients, much more than children, suffer from delay in diagnosis, lack of centralization of care, ageadjusted expertise, and AYA follow-up care. AYAs typically present with a rare tumour: either with a paediatric malignancy (e.g. acute lymphoblastic leukaemia, paediatric brain tumours), a more typical tumour of AYA age (e.g. Hodgkin's disease, germ cell cancer, melanoma, thyroid cancer) or with an adult tumour at unusual young age (e.g. gastrointestinal, lung, breast carcinomas). Next to these differences in epidemiology, the tumour biology, developmental challenges (e.g. forming relationships, becoming financially independent, having children) and treatment regimens differ between AYAs and children, and therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Furthermore, novel treatments with targeted agents or immunotherapy are more likely to be administrated to AYAs compared to children. Finally, a rare group of incurable AYA cancer patients will survive for many years, for whom health outcome and supportive care intervention data are lacking.\n\nGlobally, so far, the identification of AYA cancer patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic, biological, physiological); or combinations of influences for impaired (agespecific) health outcomes, remains largely unknown. Understanding who is at risk and why will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines, in co-creation with AYA cancer patients.\n\nObjective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among a population-based sample of AYA cancer patients.\n\nStudy design: Prospective, observational cohort study Study population: All AYAs diagnosed (18-39 years at primary diagnosis) with cancer (any type) within the first 3 months after diagnosis (eligibility window of 1 month to ensure all eligible AYA cancer patients can be included) in one of the participating centres (or treated in one of these centres) in The Netherlands.\n\nMain study parameters\u002Fendpoints: The main outcomes are medical (e.g. second tumour; survival; fertility) and psychosocial (e.g. distress) health outcomes. Other study parameters (covariates\u002Fmoderators\u002Fmediators) are characteristics of the individual (e.g. age, sex, cultural background, partner status, educational level, occupation, tumour type, disease stage, body composition, comorbid conditions, coping style), characteristics of the environment (e.g. cancer treatment, lifestyle), and genetic and biological factors (e.g. family history of cancer, stress and inflammation markers (e.g. cortisol, IL-6), microbiome).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: On an individual level, patients who participate are asked to complete questionnaires on an annual basis for at least 10 years. All sample collections will take place at three time points: 0-3 months after diagnosis (baseline), 2 and 5 years; except blood for DNA analyses which will only take place at baseline. The collection of blood, hair and faeces at three occasions is minimally invasive and the risks of blood draws, hair and fecal sampling are negligible. All safety measures and procedures will be performed according to local guidelines. Patients will not experience direct benefit from participation in the COMPRAYA study.\n\nBy participating, patients will contribute to a better insight in the prevalence of impaired medical and psychosocial (age-specific) health outcomes in AYA and evidence on factors associated with these health outcomes. This will lead to better and more personalized cancer care and supportive care tools for future AYA cancer patients.",[29,58,59,60,61,62,63],"Survivorship","Fertility Issues","Distress, Emotional","Lifestyle","Genetic Disease","Cancer","2022-02-11",{"date":66,"type":34},"2022-03-02",{"date":68,"type":34},"2021-06-18",{"date":70,"type":21},"2035-06",{"name":72,"class":41},"The Netherlands Cancer Institute",1]