- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01386411
Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer
Genes are the "blueprints" for our bodies. Some people are born with an abnormal copy ("mutation") of a gene. These people may have a higher chance of getting a disease. Different mutations in different genes cause different diseases. Some women get breast cancer because they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1 or BRCA2 also have a higher chance of getting a second breast cancer in their other breast. Because of this, women who might have a mutation may have genetic testing soon after their breast cancer diagnosis to learn about their risks of getting another cancer.
Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may also be done later, after surgery is done to treat the cancer. The investigators do not know when it is best to do genetic testing. The investigators are doing this study to try to understand whether women prefer testing before or after surgery. The investigator also want to find out how they feel about their choice later on, when their diagnosis in more in their past.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of invasive breast cancer or DCIS
- Appropriate for genetic testing, defined as if they meeting one or more of the following criteria (note that patients may be appropriate for genetic testing even if they do not meet these criteria, but NCCN and most payers recognize these groups as clearly appropriate for testing)
- Must be a primary malignancy (not recurrence), but can be second diagnosis if is a contralateral cancer and the first cancer was not treated with mastectomy
- Female age ≥18,
- If Ashkenazi Jewish: Breast cancer diagnosis ≤ 60. Subjects will be presumed to be of Ashkenazi ethnicity if Jewish religious preference is confirmed in subject and at least 1 parent, unless they explicitly endorse Sephardic, Iranian, Yemeni/Ethiopian, or Bukharan Jewish Decent, in which case non-Ashkenazi criteria will be applied.
If not Ashkenazi Jewish:
- Breast cancer diagnosis ≤ 45 OR
- Bilateral breast cancer, with first diagnosed ≤ 50 OR
- Breast cancer diagnosed at any age with a male relative with breast cancer OR
Breast cancer diagnosis ≤ 50 with one or more of the following::
- 1 or more relative with breast cancer ≤ 50 or
- 1 or more relative with ovarian cancer
- Have not completed definitive surgical treatment
- For patients planning mastectomy for treatment, has not yet undergone mastectomy
- For patients planning breast conservation for treatment, has not yet begun adjuvant radiation therapy
Exclusion Criteria:
- LCIS without invasive cancer (IDC or ILC) and without DCIS
- Previous breast cancer treated with mastectomy
- Plan for neoadjuvant chemotherapy before surgery
- Unable to complete English language questionnaires, as instruments have not been validated in non-English speaking populations
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Women with Breast Cancer
The proposed investigation is a prospective cohort study.
Women with newly diagnosed breast cancer will decide whether to undergo BRCA testing either before or after completion of local surgical treatment.
|
If they consent to enroll, they will complete an instrument evaluating their beliefs regarding the value of genetic testing (Assessment 1).
After that, they will decide whether they wish to attend an information session on genetic predisposition.
If they do, after completing that information session they will complete a follow-up instrument (Assessment 2), and will then decide to either immediately donate a sample for immediate testing, or to defer the decision until after surgery.
Women will be given the results of their genetic testing in the context of a standard results counseling session, after which they will continue with clinical care.
They will be followed for clinical decision, especially whether or not they undergo CPM.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To determine the relative proportions of women offered genetic testing after a breast cancer diagnosis who decide to have BRCA testing
기간: 2 years
|
Either before completing definitive local surgical treatment (pre-surgical testing), after definitive surgical treatment (post-surgical) Women will be evaluated for their levels of general and cancer specific distress, coping style, and stage of decision-making with respect to PM (as this is the primary clinical reason for undergoing immediate testing).
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To determine the relative proportions of women who decide to undergo prophylactic mastectomy (PM)
기간: 2 years
|
The decision-making on prophylactic mastectomy (PM) will be obtained from the immediate and delayed BRCA genetic testers at Assessment 3.
This will be a binary outcome of PM vs. no PM.
|
2 years
|
To assess the factors associated with the decision to choose pre- or post surgical testing.
기간: 2 years
|
We will compare the BRCA genetic testers (pooling immediate and delayed to boost the sample size) and the decliners on the summary scores of several psychosocial assessments using independent-sample t-tests for continuous variables (e.g., distress as measured by the BSI and IES) and non-parametric tests for categorical variables such as exact binomial test, Fisher's exact test, or the Chi-square test as appropriate (e.g., the blunters vs. monitors dichotomization) .
|
2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark Robson, MD, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
유방암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
BRCA testing and questionnaire assessments에 대한 임상 시험
-
Ankara Yildirim Beyazıt University모병