NCT04976803已完成不适用
A Tissue Collection Study to Explore the Correlation Between ATM Genetic Alterations by Next-Generation Sequencing and ATM Loss-of-Protein Via IHC (ATR-ID Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 3
- 主要终点
- Number of patients with loss of ATM protein
研究概览
简要总结
This study examines the correlation between ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
详细描述
The purpose of this study is to address whether ATM genomic aberrations could be used to enrich for patients with ATM LoP. Screening of unselected patient populations for ATM protein loss is likely to a lead to high failure rate by IHC testing, as the prevalence of this is expected to be low. This study could allow for identification of the types of ATM aberrations that lead to ATM LoP, and thus significantly decrease IHC failure rate by pre-selecting patients harboring such aberrations. In this study the investigator will be collecting archival tumor tissue or fresh tissue which will be assessed for ATM LoP and compared to NGS data. Additionally, patients whose tumors exhibit ATM LoP within this study could potentially enroll onto the treatment study REFMAL 721/ART0380C001.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following criteria in order to be included in the research study:
- •All patients (Groups A, B, and C) must meet the following criteria:
- •Previous genetic testing of ATM genomic aberrations.
- •≥18 years of age.
- •All living patients (Groups B and C) must also meet the additional criteria:
- •Signed written informed consent to access archival tissue, if available.
- •All Group C patients must also meet the additional criteria:
- •Provided signed written informed consent to collect a fresh core biopsy.
- •Have a non-irradiated, biopsiable tumor site to allow sampling for analysis via IHC for loss of ATM protein.
- •Potentially eligible for REFMAL 721/ART0380C001:
- •Have not received a previous treatment targeting the ATR/CHK1 pathway.
- •If patients have a germline BRCA mutation or a cancer with a somatic BRCA mutation or which is HRD positive and for which there is an approved PARP inhibitor, patients should have received such treatment.
- •Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator
- •Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study.
- •Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
排除标准
- •There are no exclusion criteria for patients in Group A and Group B.
- •Group C patients who meet any of the following criteria will be excluded from study entry:
- •Have a significant bleeding disorder or vasculitis or had a Grade 3 bleeding episode within 12 weeks prior to enrollment.
- •Presumed ineligible for enrollment to REFMAL 721/ART0380C001:
- •Psychological, familial, sociological, or geographical conditions that that would compromise the patient's ability to adhere to future procedures likely in a Phase I protocol (such as REFMAL 721/ ART0380C001).
- •Women who are pregnant, breast feeding, or who plan to become pregnant within the next 6 months.
- •Men who plan to father a child within the next 6 months.
- •Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to a future protocol (REFMAL 721/ ART0380C001) including:
- •One or more opportunistic HIV/AIDs-related infections within the past 12 months.
- •Documented active or chronic infection with hepatitis B virus (positive hepatitis B surface antigen [+HBsAg]), or hepatitis C virus.
- •Known history of clinical diagnosis of tuberculosis.
- •Have had a malignancy prior to the current malignancy. Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the medical monitor, are eligible for this study.
- •Have evidence of interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
- •Have moderate or severe cardiovascular disease, such as the following:
- •Have the presence of cardiac disease.
- •Have valvulopathy that is severe, moderate, or deemed clinically significant.
- •Have documented major electrocardiogram (ECG) abnormalities which are clinically significant.
- •Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (patients receiving anticonvulsants are eligible).
结局指标
主要结局
Number of patients with loss of ATM protein
时间窗: 12 months
ATM protein expression levels from tumor tissue assessed by immunohistochemistry (IHC)
次要结局
- Number of ATM genomic aberrations that lead to ATM LoP(12 months)
- Rate of loss of function (LoF) of the ATM gene in patients with genomic aberrations in the ATM gene(12 months)
- Number of potential patients with loss of ATM protein eligible for study REFMAL 721/ART0380C001(12 months)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
The Applanation Tonometry in GCA PilotGiant Cell ArteritisNCT05703763Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal146
已完成
不适用
Genetic Load and Phenotype in Aggressive AMDAge-related Macular DegenerationNCT01650948Sequenom, Inc.100
招募中
不适用
Next Generation Sequencing (NGS) in Familial Acute Myeloid Leukemia and Myelodisplastic SyndromesLeukemiaNCT03058588Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia20
已完成
不适用
Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAMMultiple Sclerosis, Relapsing-RemittingNCT05684016George Washington University75
招募中
不适用
Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)ATTR AmyloidosisCardiopathyLumbar Spine StenosisHip ProsthesisKnee ProsthesisCarpal Tunnel SyndromeNCT06367842Institut Mutualiste Montsouris150