NCT02067754

Brief Summary

The investigators planned this study to Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy : Extra blood sample collection during routine blood sampling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

February 10, 2014

Last Update Submit

May 17, 2019

Conditions

Gastric Cancer

Keywords

The mutation profiling of circulating free DNA

Outcome Measures

Primary Outcomes (1)

  • Circulating tumor cell

    To survey the mutation profiling of circulating free DNA in gastrointestinal cancer, genitourinary cancer, and rare cancer.

    1years

Secondary Outcomes (1)

  • mutation profiling of circulating free DNA

    1years

Other Outcomes (1)

  • Circulating Free DNA Analysis in Gastrointestinal Cancer, Genitourinary Cancer

    From date of start of chemotherapy treatment by Circulating free DNA until the date of first progression or date of death from any cause.

Study Arms (1)

metastatic Cancer

metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pathologically confirmed cancer patients

You may qualify if:

  • Patients older than 20 years
  • Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy
  • Written informed consent form

You may not qualify if:

  • Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical center

Seoul, 135-710, South Korea

Location

Related Publications (2)

  • 1. Lower EE etal. Impact of metastatic ER and PR status on survival. Breast Cancers and Treat. 90. 65-75. 2005. 2. Regitnig P et al. Change of Her-2/neu status in a subset of distant metastases from breast carcibnoma. J Pathol. 203 94) 918-26, 2004. 3. Cristofanilli M. Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med 351:781-91. 4. Riethdorf S, Fritsche H, Muller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Janickje F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res 13:920-8. 2007 5. Cristofanilli M, Broglio KR, Guarneri V, Jackson S, Fritsche HA, Islam R, Dawood S, Reuben JM, Kaum SW, Lara JM, Krishnamurthy S, Ueno NT, Hortobagyi GN, Valero V. Circulating tumor cells in metastatic breast cancer: biologic staging beyond tumor burden. Clin Breast Cancer 7:471-9, 2007.

    BACKGROUND

  • Kim ST, Lee WS, Lanman RB, Mortimer S, Zill OA, Kim KM, Jang KT, Kim SH, Park SH, Park JO, Park YS, Lim HY, Eltoukhy H, Kang WK, Lee WY, Kim HC, Park K, Lee J, Talasaz A. Prospective blinded study of somatic mutation detection in cell-free DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients. Oncotarget. 2015 Nov 24;6(37):40360-9. doi: 10.18632/oncotarget.5465.

    PMID: 26452027DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* From each enrolled patient who meets the inclusion/exclusion criteria, blood samples will be collected 10 mL blood sample will be collected at the baseline and every cycles of tumor evaluation. * 20 of 5µm unstained sections will be collected at the time of study entry.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jeeyun Lee, MD,PhD

    Division of oncologyu, Department of Medicine, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 20, 2014

Study Start

September 11, 2013

Primary Completion

January 1, 2018

Study Completion

February 9, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

KR(1)