NCT02602938

Brief Summary

The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 9, 2015

Last Update Submit

November 12, 2015

Conditions

Epithelial-Mesenchymal TransitionCirculating Tumor Cells

Keywords

aspirincirculating tumor cellsmetastatic breast cancermetastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Intervention completed

    2-months follow-up completed and the CTCs' assessment was evaluated three times by Canpatrol technology, the tumor burden was evaluated by MRI or CT.

    2 months

Secondary Outcomes (1)

  • Disease progression

    2 months

Study Arms (1)

aspirin

EXPERIMENTAL

* The included patients will be administered with aspirin (100mg) orally once a day in 28-day cycles. * The CTC was evaluated at baseline, and every 28 days for 2 months.

Drug: Aspirin

Interventions

AspirinDRUG

Take aspirin (100mg) orally once a day for 2 months

Also known as: acetylsalicylic acid
aspirin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age from 18-75 years old.
  • Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
  • Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted.
  • Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
  • PS score ≤ 3
  • Anticipated survival time ≥ 3 months
  • CTCs≥5 / 7.5ml blood

You may not qualify if:

  • Allergic to aspirin or other types of non-steroid
  • History of hemorrhage of digestive tract or other hemorrhagic disease
  • Plan to receive surgery within the time frame of the trial
  • Medication history of aspirin or other types of anti-platelets drug within one months before the trial
  • Women in pregnant or lactation period
  • Any psychological or objective problem may influence the compliance of the patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Related Publications (4)

  • Ksiazkiewicz M, Markiewicz A, Zaczek AJ. Epithelial-mesenchymal transition: a hallmark in metastasis formation linking circulating tumor cells and cancer stem cells. Pathobiology. 2012;79(4):195-208. doi: 10.1159/000337106. Epub 2012 Apr 4.

    PMID: 22488297BACKGROUND

  • Rothwell PM, Wilson M, Price JF, Belch JF, Meade TW, Mehta Z. Effect of daily aspirin on risk of cancer metastasis: a study of incident cancers during randomised controlled trials. Lancet. 2012 Apr 28;379(9826):1591-601. doi: 10.1016/S0140-6736(12)60209-8. Epub 2012 Mar 21.

    PMID: 22440947BACKGROUND

  • Maity G, De A, Das A, Banerjee S, Sarkar S, Banerjee SK. Aspirin blocks growth of breast tumor cells and tumor-initiating cells and induces reprogramming factors of mesenchymal to epithelial transition. Lab Invest. 2015 Jul;95(7):702-17. doi: 10.1038/labinvest.2015.49. Epub 2015 Apr 13.

    PMID: 25867761BACKGROUND

  • Yang L, Lv Z, Xia W, Zhang W, Xin Y, Yuan H, Chen Y, Hu X, Lv Y, Xu Q, Weng X, Ni C. The effect of aspirin on circulating tumor cells in metastatic colorectal and breast cancer patients: a phase II trial study. Clin Transl Oncol. 2018 Jul;20(7):912-921. doi: 10.1007/s12094-017-1806-z. Epub 2017 Dec 14.

    PMID: 29243075DERIVED

MeSH Terms

Conditions

Neoplastic Cells, CirculatingBreast NeoplasmsColorectal Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Chao Ni, Doctor

CONTACT

+8613989463951davenc@163.com

Yun Chen, Doctor

CONTACT

+8613858087167hlqm1986@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Ni

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 11, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

CN(1)