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Aspirin on CTCs of Advanced Breast and Colorectal Cancer (ACABC)

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ClinicalTrials.gov Identifier: NCT02602938
Recruitment Status : Unknown
Verified November 2015 by Chao Ni, Zhejiang Provincial People’s Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Chao Ni, Zhejiang Provincial People’s Hospital

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.

Condition or disease Intervention/treatment Phase
Epithelial-Mesenchymal Transition Circulating Tumor Cells Drug: Aspirin Phase 2

Detailed Description:

BACKGROUND:

  • Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis.
  • Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis.
  • Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer.

OBJECTIVES:

  • Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer;
  • Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer.

ELIGIBILITY:

  • 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.
  • No disease of hemorrhagic tendency or history of non-steroid drug allergy.
  • CTCs≥5 / 7.5ml blood

STUDY DESIGN:

  • Aspirin will be administered orally once a day in 28-day cycles.
  • The CTC was evaluated every 28 days for 2 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: aspirin
  • 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
Take aspirin (100mg) orally once a day for 2 months
Other Name: acetylsalicylic acid




Primary Outcome Measures :
  1. Intervention completed [ Time Frame: 2 months ]
    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.


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: 2 months ]
    The tumor burden would be examined by MRI or CT once a month, if we find the cancer progressed and chemotherapy is needed, the patient will be withdraw.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602938


Contacts
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Contact: Chao Ni, Doctor +8613989463951 davenc@163.com
Contact: Yun Chen, Doctor +8613858087167 hlqm1986@163.com

Locations
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China, Zhejiang
Zhejiang provincial people's hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact: Jinwen Qi    +8613758248488    11118118@zju.edu.cn   
Contact: Chao Ni    +8613989463951    davenc@163.com   
Sponsors and Collaborators
Zhejiang Provincial People’s Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chao Ni, Dr.Ni, Zhejiang Provincial People’s Hospital
ClinicalTrials.gov Identifier: NCT02602938     History of Changes
Other Study ID Numbers: 2015KY163
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Chao Ni, Zhejiang Provincial People’s Hospital:
aspirin
circulating tumor cells
metastatic breast cancer
metastatic colorectal cancer

Additional relevant MeSH terms:
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Aspirin
Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics