- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00033527
INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
A Double-Blinded, Placebo-Controlled, Parallel Group Study Of Uridine 5'-Triphosphate (UTP) Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology
RATIONALE: INS316 may produce a better sputum sample for laboratory analysis and may provide a less invasive method of diagnosing lung cancer.
PURPOSE: Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer in patients suspected of having lung cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the number of lung cancer diagnoses obtained from cytological evaluation of sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for spontaneous expectoration of sputum in patients with suspected lung cancer.
- Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients.
- Compare the amount of sputum collected from patients using these methods.
- Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients.
- Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel, multicenter study. Patients are stratified according to tumor size and location as visualized by chest radiography, CT scan, or positron-emission tomography scan (peripheral tumor (distal to the subsegmental bronchi) no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than 2 cm in diameter). Patients are randomized to one of two arms.
Prior to dosing with sputum induction adjunct, all patients expectorate sputum spontaneously.
- Arm I: Patients receive a single dose of INS316 by inhalation.
- Arm II: Patients receive a single dose of placebo (normal saline) by inhalation.
In both arms, patients expectorate sputum during dosing, immediately after dosing, and then within 15, 30, and 60 minutes after dosing.
Patients are followed on day 1 after dosing, for up to 8 weeks until a diagnosis is made, and then up to 3 months if diagnosis is malignant.
PROJECTED ACCRUAL: Approximately 800 patients (or until 600 confirmed diagnoses of malignancy are made) will be accrued for this study.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Suspected of having primary lung cancer by chest radiography, CT scan, or positron-emission tomography scan with symptoms, risk profile, or history suggestive of malignancy
- No prior confirmed diagnosis for current suspicious lung tumor
- Expected to have a histological or cytological confirmation within 8 weeks after study completion
- No prior treatment for current suspicious tumor unless current lesion is recurrence of same tumor (in same location) for which prior treatment was received at least 180 days prior to study
- FEV_1 at least 40% predicted
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent comorbid condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
Surgery:
- At least 4 days since prior pulmonary fine needle aspiration biopsy
- No concurrent mediastinoscopy or thoracotomy
Other:
- At least 4 days since prior bronchoscopic examination
- At least 3 days since prior sputum induction
- At least 30 days since prior investigational drugs (including INS316) or experimental therapy
- No concurrent medication that would preclude study participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 마스킹: 더블
공동 작업자 및 조사자
수사관
- 연구 의자: Jenny T. Mao, MD, Jonsson Comprehensive Cancer Center
연구 기록 날짜
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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