NCT00899912已完成不适用
Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 10
- 主要终点
- Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
研究概览
简要总结
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield RNA of adequate quality to perform DNA microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer.
Secondary
- Compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol RTOG-0232.
- Find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232.
- Find gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, locally confined adenocarcinoma of the prostate
- •Zubrod performance 0-1
- •Clinical stages T1c - T2b, N0, M0
- •Combined Gleason score 7 if prostate specific antigen (PSA) < 10, combined Gleason score < 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
- •American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
- •Age ≥ 18 years old and must sign a study-specific informed consent form
排除标准
- •No clinically or pathologically involved lymph nodes
- •No distant metastases or significant obstructive symptoms
- •No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
- •No previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
- •No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
- •No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
结局指标
主要结局
Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
时间窗: Specimens collected at the time of brachytherapy
次要结局
- Gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure(After microarray analysis of tissue and primary endpoint analysis of RTOG 0232)
- Comparison of genes to determine which are expressed differentially before and after radiotherapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232(After microarray analysis of tissue and primary endpoint analysis of RTOG 0232)
- Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232(After microarray analysis of tissue and primary endpoint analysis of RTOG 0232)
研究者
研究点 (10)
Loading locations...
相似试验
Unknown
不适用
Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the EsophagusEsophageal CancerNCT00766480University of Toyama160
招募中
不适用
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy ParticipantsUnspecified Adult Solid Tumor, Protocol SpecificNCT00992303University of Texas Southwestern Medical Center10,000
进行中（未招募）
不适用
Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking StudySolid TumorsHematologic MalignanciesNCT02457962Mayo Clinic15,000
已完成
不适用
Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and ChemotherapyColorectal CancerNCT00918827Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan2,128
已完成
不适用
Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)Radiation TherapyCancer of AnusCancer of BladderCancerCancer of CervixCancer of ColonCancer of RectumCancer of EsophagusCancer of GallbladderCancer of LiverCancer of OvaryCancer of PancreasCancer of ProstateCancer of Kidney and Renal PelvisCancer of StomachCancer of TestisCancer of UterusCancer of Uterus and CervixCancer of KidneyNCT03133286DxTerity Diagnostics16