난소암, 복막암, 나팔관암의 재발 예측인자
상피성 난소암, 원발성 복막암 및 나팔관암 환자의 1차 임상적 관해에 대한 단백학적 평가에 관한 다기관 연구: 재발의 단백질 지문 프로파일 개발
This study will develop a blood test that can be used to predict a relapse of ovarian, peritoneal, or fallopian tube cancer. The type of testing is called proteomics, or the study of proteins in living cells. The test will identify certain proteins that might represent a pattern, or "fingerprint," indicating increased risk of disease relapse.
Women with Stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is in remission may be eligible for this study. Candidates are screened with a medical history and physical examination, blood tests, review of pathology report from surgery, and computed tomography (CT) or magnetic resonance imaging (MRI) scans of the abdomen and pelvis (and chest if the cancer spread to the chest).
Participants have a clinic visit every 3 months for a physical examination (including a pelvic examination), blood draw for routine and research tests, and review of how they have been feeling. Every 6 months they have CT scans of the abdomen, pelvis, and possibly the chest. When a patient has been in remission for 4 years, blood draws are done every 6 months and CT scans are done yearly. Patients whose cancer returns (based on a CA-125 blood test, CT scans, or physical examination) end their participation in the study. Patients with an abnormal CT scan or physical examination may be asked to undergo a tumor biopsy (surgical removal of a piece of tumor tissue) for research purposes.
연구 개요
상세 설명
Background:
Over 80% of patients with advanced stage epithelial ovarian cancer will relapse
Serum biomarkers are needed for predictors of persistent disease and relapse
CA-125 is a less than satisfactory clinical tool for detecting relapse
A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening.
Objectives:
To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
To determine the sensitivity and specificity of the proteomic signature profiles for relapse
To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression
To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse.
To detect the impact of study participation on quality of life.
To collect epidemiological data for patients in the target population
Eligibility:
Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.
Entry within 12 weeks of last administration of chemotherapy.
S/P surgical debulking and completion of primary therapy with platinum/taxane-containing chemotherapy of no more than a total of 8 cycles.
Laboratory evidence of good end organ function.
Design:
Phase of Trial: Biomarker/Laboratory Analysis.
Number of patients to be enrolled: 400
Planned statistical analysis for primary endpoint: Training set to include 100 women, half of whom are in remission and half of whom have recurrent disease. Validation set will include 200 women, half of whom are in remission and half of whom have recurrent disease.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국
- University of Alabama at Birmingham
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California
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Los Angeles, California, 미국, 90048-1804
- Cedars Sinai Medical Center
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Illinois
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Evanston, Illinois, 미국
- Evanston Northwestern University Hospital
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital, Dana Farber
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New York
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New York, New York, 미국, 10016
- New York University School of Medicine
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Texas
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Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, 미국, 28104
- University of Washington/Fred Hutchinson Cancer Research Center
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Seattle, Washington, 미국
- Pacific Ovarian Cancer Research Consortium at FHCRC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.
설명
- INCLUSION CRITERIA:
2.1.1<TAB>All patients in first complete response from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by: normal CA-125, normal post-hysterectomy physical exam, no evidence of disease on abdominopelvic CT scan (or other noninvasive reassessment, e.g. MRI). PET scans are not acceptable for confirmation of complete response.
2.1.2<TAB>Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry.
2.1.3<TAB>Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy).
2.1.4<TAB>S/P surgical debulking and completion of primary therapy with platinum/taxane -containing chemotherapy of no more than 8 total cycles.
2.1.5<TAB>Patients who undergo second look laparotomy or laparoscopy and have microscopic residual disease but who elect not to have treatment will be eligible to enroll.
2.1.6<TAB>Histology slides adequate to confirm the pathology and staging must be submitted to the coordinating center within 3 months of enrollment. (If available, a sample of frozen primary tumor should also be forwarded).
2.1.7<TAB>Patients must be able and willing to provide informed consent to participate in the trial.
2.1.8<TAB>Patients must have laboratory evidence of good end organ function by criteria in Table 1 below. The upper limit of normal is based upon each registering center's laboratory normal ranges.
Laboratory based inclusion criteria:
Laboratory Test: AST(SGOT) and ALT(SGPT)
Required value: less than or equal to 2.5 times the institutional upper limit of normal creatinine
OR
Laboratory Test: Creatinine
Required value: Less than or equal to 2.0
Laboratory Test: Creatinine clearance
Required Value: Greater than or equal to 45 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
EXCLUSION CRITERIA:
2.2.1<TAB>Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer.
2.2.2<TAB>Patients may not be receiving chemotherapy (therapeutic or consolidation), maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer therapies such as tamoxifen and raloxifene will not be permitted while on study.
2.2.3<TAB>Patients with a life expectancy of less than 6 months for any reason.
2.2.4 <TAB>Patients with a history of other invasive malignancies within the past five years prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or basal or squamous cell skin cancers.
2.2.5 <TAB>Complementary and alternative agent use is discouraged on this study due to the possibility that the use of these agents may alter the serum protein pattern. The Institutional Principal Investigator will have discretion as to whether complementary or alternative agent usage will prevent eligibility on a case by case basis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
patients
Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated
기간: End of specimen collection
|
Multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated |
End of specimen collection
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Elise C Kohn, M.D., National Cancer Institute (NCI)
간행물 및 유용한 링크
일반 간행물
- Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7. doi: 10.1016/S0140-6736(02)07746-2.
- Patsner B, Orr JW Jr, Mann WJ Jr, Taylor PT, Partridge E, Allmen T. Does serum CA-125 level prior to second-look laparotomy for invasive ovarian adenocarcinoma predict size of residual disease? Gynecol Oncol. 1990 Sep;38(3):373-6. doi: 10.1016/0090-8258(90)90076-w.
- Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 040232
- 04-C-0232
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD 공유 기간
Clinical data are available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD 공유 액세스 기준
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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