Epithelial-Mesenchymal TransitionPhase 2ACABCNCT02602938
Aspirin on CTCs of Advanced Breast and Colorectal Cancer
A Phase 2 study testing Aspirin in people with Epithelial-Mesenchymal Transition and Circulating Tumor Cells, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epithelial-Mesenchymal Transition, Circulating Tumor Cells
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, 310014
Jinwen Qi, +8613758248488, 11118118@zju.edu.cn
Chao Ni, +8613989463951, davenc@163.com
About this study
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.
Read the 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.
- Being tested
- Aspirin
- Keywords
- aspirin, circulating tumor cells, metastatic breast cancer, metastatic colorectal cancer
- Medical subject headings
- Neoplastic Cells, Circulating, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called acetylsalicylic acid
Take aspirin (100mg) orally once a day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
Disease progression
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Epithelial-Mesenchymal TransitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Ni, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602938
- Sponsor's protocol ID
- 2015KY163
- Acronym
- ACABC
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22488297Rothwell 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.
PubMed 22440947Maity 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.
PubMed 25867761Yang 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.
PubMed 29243075
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin on CTCs of Advanced Breast and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02602938
- Acronym / sponsor ID
- ACABC / 2015KY163
- Keywords
- aspirin, circulating tumor cells, metastatic breast cancer, metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aspirin | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: acetylsalicylic acidTake aspirin (100mg) orally once a day for 2 months | Drug | aspirin |
Primary outcome
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.
1 secondary outcome
Disease progression
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Background: PubMed 22488297Ksiazkiewicz 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.
- Background: PubMed 22440947Rothwell 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.
- Background: PubMed 25867761Maity 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.
- Derived from this study: PubMed 29243075Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Epithelial-Mesenchymal Transition and Circulating Tumor Cells, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Ni, Doctor (+8613989463951, davenc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention completed (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602938, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.