Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
연구 개요
상태
상태
정황
정황
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Cohort 1 and 2:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
- Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Cohort 3:
- Patients 18 years of age or older at SCLC diagnosis
- Confirmed diagnosis of SCLC not earlier than October 2013
- Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
- Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
- Signed informed consent (where required as per local requirements)
Exclusion Criteria:
- Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.
Other Inclusion/Exclusion criteria may apply
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
|
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
|
|
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
|
|
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Distribution of Patient Demographic Characteristics
기간: At baseline
|
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors |
At baseline
|
|
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
기간: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
기간: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
기간: At baseline
|
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms |
At baseline
|
|
Distribution of treatment patterns in patients with ED-SCLC
기간: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
|
Distribution of treatment patterns in patients with LD-SCLC
기간: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
|
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
기간: Approximately 44 months
|
Details on patients prior treatment Patterns will be summarized using descriptive statistics
|
Approximately 44 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Composite of SCLC-related healthcare resource utilization (HCRU)
기간: Approximately 44 months
|
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
|
Approximately 44 months
|
|
Overall survival (OS)
기간: Approximately 44 months
|
Approximately 44 months
|
|
|
Progression-free survival (PFS)
기간: Approximately 44 months
|
Approximately 44 months
|
|
|
Objective response rate (ORR)
기간: Approximately 44 months
|
Approximately 44 months
|
|
|
Mortality rate
기간: Approximately 44 months
|
Approximately 44 months
|
|
|
Treatment-related adverse events (AEs) leading to discontinuation
기간: Approximately 44 months
|
Approximately 44 months
|
|
|
Incidence of surgery as cancer-directed therapy
기간: Approximately 44 months
|
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of radiation therapy as cancer-directed therapy
기간: Approximately 44 months
|
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of best supportive care (BSC)
기간: Approximately 44 months
|
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
|
Incidence of palliative care
기간: Approximately 44 months
|
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
|
Approximately 44 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
폐암에 대한 임상 시험
-
NCT03987217완전한피로 | 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) v8
-
NCT01524783완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin
-
NCT06216249모병전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT07468903모병전립선 선암종 | 2기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8
-
NCT04399824빼는전립선 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) v8
-
NCT07267247완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제
-
NCT04624256모집하지 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) v8
-
NCT06870396초대로 등록부신 종양 | 페로 크로 모세포종 및 paraganglioma (PPGL) | Adrenocorticol Cancer (ACC)