Unique ID issued by UMIN | UMIN000037505 |
---|---|
Receipt number | R000042740 |
Scientific Title | Validation study of the prognostic and predictive value of TP53 signature for breast cancer |
Date of disclosure of the study information | 2019/09/18 |
Last modified on | 2021/07/27 14:16:37 |
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
The aim of this study is to validate whether the TP53 status diagnosed by the TP53 signature diagnostic kit can predict the prognosis and the therapeutic effect of neoadjuvant chemotherapy in breast cancer patients.
Efficacy
Confirmatory
Not applicable
Pathological complete response rate
Observational
Not applicable |
Not applicable |
Female
The subjects are the patients enrolled in the following five clinical trials conducted by JBCRG and OOTR.
i. JBCRG-01 (n=202)
ii. JBCRG-02 (n=31)
iii. JBCRG-02' (n=19)
iv. JBCRG-03 (n=130)
v. OOTR-N003 (n=500)
In addition, perioperative chemotherapy-free hormone receptor positive breast cancer (HR+BC) patients will be collected targeting at 340 cases.
Selection criteria for perioperative chemotherapy-free HR+BC cases are as follows according to the eligibility criteria of the above five clinical trials.
Cases that satisfy all the following 1 to 7
1. Cases with histologically confirmed primary breast cancer (invasive cancer) and undergone curative resection
2. Cases in which TNM at diagnosis satisfies the following {cT1 c-3 cN0 cM0 (> 1 cm) / cT1-3 cN1 cM0}
3. Cases in which chemotherapy were not given as preoperative or postoperative adjuvant therapy (cases in which endocrine therapy were given are acceptable)
4. 20 years old or older and less than 70 years old
5. Cases in which regular follow-up has been performed at the facility where surgery for breast cancer was performed and of whom sufficient prognostic information can be obtained (Follow-up period must be over 5 years in cases without recurrence).
6. Cases in which the following samples can be submitted
Cases with preoperative endocrine therapy: Biopsy tumor samples obtained before endocrine therapy (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens)
Cases without preoperative endocrine therapy: Biopsy tumor samples at diagnosis or tumor samples resected by surgery (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens)
7. Cases diagnosed with primary breast cancer between August 2005 and July 2009
The number of cases in each facility is limited to 60 cases, and all eligible cases after August 2005 have to be registered consecutively.
1. Male
2. Cases judged by investigator to be unfit to be enrolled into the study
840
1st name | Chikashi |
Middle name | |
Last name | Ishioka |
Institute of Development, Aging and Cancer, Tohoku University
Department of Clinical Oncology
980-8575
4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
022-717-8543
chikashi@tohoku.ac.jp
1st name | Shin |
Middle name | |
Last name | Takahashi |
Institute of Development, Aging and Cancer, Tohoku University
Department of Clinical Oncology
980-8575
4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
022-717-8543
shin.takahashi.e7@tohoku.ac.jp
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Japanese Governmental office
Tohoku University Hospital Research Ethics Committee
1-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
NO
2019 | Year | 09 | Month | 18 | Day |
Partially published
800
A total of 800 specimens were collected from 23 sites in Japan, and TP53 signature data were obtained for a total of 753 cases, excluding insufficient specimen cases (wild-type (wt) 361 cases and mutant (mt) 392 cases).In a preoperative chemotherapy cohort, the pCR ratio in the mt group was significantly higher than that of wt group (the estimate of the common odds ratio of the mt group for the wt group: 5.599, 95% CI: 1.876-16.705, p=0.0008).
2021 | Year | 07 | Month | 27 | Day |
Completed
2019 | Year | 09 | Month | 10 | Day |
2019 | Year | 09 | Month | 26 | Day |
2019 | Year | 09 | Month | 26 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
We verify that the pCR ratio in patients diagnosed with mt by TP53 signature is higher than that in patients diagnosed with wt in patients treated with preoperative chemotherapy.
To match the patients background between TP53 signature status, we use propensity score (PS) estimated by logistic regression analysis. The covariates are ER, PgR, Ki67, age, menopausal status, tumor diameter, lymph node status and vascular invasion. We divide patients into 3 groups by PS so that the number of patients in the stratum is equal. The pCR ratio, the 95% confidence interval by the Cloper-Pearson method and the odds ratio are calculated in the patients with mt and wt by TP53 signature, respectively. In addition, the null hypothesis that the common odds ratio is 1 is tested at a two-sided significance level of 5% using the Mantel-Haenszel test.
2019 | Year | 07 | Month | 26 | Day |
2021 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042740