Ovarian Cancer
Conditions
Interventions
Gold Standard:pathological examination
Index test:serum 
of 
degalactosed 
14-3-3 
zeta, 
CPG, 
Tn-CA125, 
T-CA125
Sponsors
Obstetrics and Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
31 Years to No maximum
Inclusion criteria
Inclusion criteria: Part 1: Early diagnosis of ovarian cancer 1. Female aged >30 years; 2. Pathologically conformed with ovarian cancer, serous adenocarcinoma of fallopian tube or peritoneum, other malignance rise from ovaries, borderline ovarian tumor, benign ovarian tumor, ovarian masses other than tumor, or pelvic inflammatory disease, or apparently healthy woman; 3. Did not receive any surgery, chemotherapy, radiation therapy for the indexed disease before been enrolled; 4. Provided written informed consent. Part 2: Screening of ovarian cancer among high risk or suspected populations 1. Female aged >30 years; 2. Free of ovarian cancer before been enrolled; 3. Meet any of the criterias listed below: (1) Patients with a history of malignancies from breast, colon, rectum, uterus, stomach, pancreas, gall bladder, liver (exclude virus related hepatocarcinoma), kidney, skin, blood cells, and/or brain; (2) Those who has relatives by blood (linear within five or collateral within three generations) affected with malignancies from ovary, breast, colon, rectum, uterus, stomach, pancreas, gall bladder, liver (exclude virus related hepatocarcinoma), kidney, skin, blood cells, prostate, and/or brain; (3) Carrier of gene mutations in BRCA1/2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM; (4) Those who received medical ovulation induction; (5) Patients with endometriosis; (6) Patients with a pelvic mass according to image examinations; (7) Those with elevated serum CA125, HE4, CA199, and/or CEA levels; 4. Provided written informed consent; 5. Provided reliable contact information for follow up. Part 3: Differential diagnosis of ovarian cancer among patients with elevated serum CA125 levels 1. Female aged >30 years; 2. Serum CA125 level >35U/ml; 3. Meet any of the criterias listed below: (1) Pregnant or non-pregnant women with pelvic masses that is pathologically conformed as ovarian cancer, serous adenocarcinoma of fallopian tube or peritoneum, other malignances that rise from ovary, borderline ovarian tumor, benign ovarian tumor, ovarian masses other than tumor, or pelvic inflammatory disease; (2) Non-pregnant women diagnosed with certain non-gyencological disease according to its corresponding criteria; (3) Apparently healthy woman, or woman with normal pregnancy; 4. Did not receive any surgery, chemotherapy, radiation therapy for the indexed disease before been enrolled; 5. Provided written informed consent.;Inclusion criteria: Part 1: Early diagnosis of ovarian cancer 1. Female aged >30 years; 2. Pathologically conformed with ovarian cancer, serous adenocarcinoma of fallopian tube or peritoneum, other malignance rise from ovaries, borderline ovarian tumor, benign ovarian tumor, ovarian masses other than tumor, or pelvic inflammatory disease, or apparently healthy woman; 3. Did not receive any surgery, chemotherapy, radiation therapy for the indexed disease before been enrolled; 4. Provided written informed consent. Part 2: Screening of ovarian cancer among high risk or suspected populations 1. Female aged >30 years; 2. Free of ovarian cancer before been enrolled; 3. Meet any of the criterias listed below: (1) Patients with a history of malignancies from breast, colon, rectum, uterus, stomach, pancreas, gall bladder, liver (exclude virus related hepatocarcinoma), kidney, skin, blood cells, and/or brain; (2) Those who has relatives by blood (linear within five or collateral within three generations) affected with malignancies from ovary, breast, colon, rectum, uterus, stomach, pancreas, gall bladder, liver (exclude virus related hepatocarcinoma), kidney, skin, blood cells, prostate, and/or brain; (3) Carrier of gene mutations in BRCA1/2, MLH1, MSH2, MSH6, PMS2, and/or EPCAM; (4) Those who received medical ovulation induction; (5) Patients with endometriosis; (6) Patients with a pelvic mass according to image examinations; (7) Those with elevated serum CA125, HE4, CA199, and/or CEA levels; 4. Provided written informed consent; 5. Provided reliable contact information for follow up. Part 3: Differential diagnosis of ovarian cancer among patients with elevated serum CA125 levels 1. Female aged >30 years; 2. Serum CA125 level >35U/ml; 3. Meet any of the criterias listed below: (1) Pregnant or non-pregnant women with pelvic masses that is pathologically conformed as ovarian cancer, serous adenocarcinoma of fallopian tube or peritoneum, other malignances that rise from ovary, borderline ovarian tumor, benign ovarian tumor, ovarian masses other than tumor, or pelvic inflammatory disease; (2) Non-pregnant women diagnosed with certain non-gyencological disease according to its corresponding criteria; (3) Apparently healthy woman, or woman with normal pregnancy; 4. Did not receive any surgery, chemotherapy, radiation therapy for the indexed disease before been enrolled; 5. Provided written informed consent.
Exclusion criteria
Exclusion criteria: Part 1: Early diagnosis of ovarian cancer 1. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 2. Patients with malignancies other than ovarian cancer; 3. Patients under emergency conditions: unconscious, having a fever (>38 degree C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.; 4. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 5. Having mental disease that requires medical therapies. Part 2: Screening of ovarian cancer among high risk or suspected populations 1. Lack of ovary and fallopian tube bilaterally due to surgery or other reasons; 2. Newly diagnosed with or having a history of ovarian cancer; 3. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 4. Patients with malignancies other than ovarian cancer; 5. Patients under emergency conditions: unconscious, having a fever (>38°C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.. 6. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 7. Having mental disease that requires medical therapies. Part 3: Differential diagnosis of ovarian cancer among patients with elevated serum CA125 levels 1. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 2. Having 2 or more conditions that may lead to serum CA125 elevation (except for pregnancy); 3. Having a history of malignancies; 4. Patients under emergency conditions: unconscious, having a fever (>38°C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.. 5. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 6. Having mental disease that requires medical therapies.;Exclusion criteria: Part 1: Early diagnosis of ovarian cancer 1. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 2. Patients with malignancies other than ovarian cancer; 3. Patients under emergency conditions: unconscious, having a fever (>38 degree C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.; 4. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 5. Having mental disease that requires medical therapies. Part 2: Screening of ovarian cancer among high risk or suspected populations 1. Lack of ovary and fallopian tube bilaterally due to surgery or other reasons; 2. Newly diagnosed with or having a history of ovarian cancer; 3. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 4. Patients with malignancies other than ovarian cancer; 5. Patients under emergency conditions: unconscious, having a fever (>38°C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.. 6. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 7. Having mental disease that requires medical therapies. Part 3: Differential diagnosis of ovarian cancer among patients with elevated serum CA125 levels 1. Be pregnant, had a delivery or abortion within 4 weeks, or having gestational trophoblastic diseases; 2. Having 2 or more conditions that may lead to serum CA125 elevation (except for pregnancy); 3. Having a history of malignancies; 4. Patients under emergency conditions: unconscious, having a fever (>38°C), with unstable vital signs, having a cardiac-pulmonary event, having an acute abdomen, etc.. 5. Suffering dysfunction of important inner organs: serum level of liver enzymes > 5 folds of the upper limit of the normal range (ULN), serum creatinine level > 3 folds of ULN, serum amylase level >2 folds of ULN, cardiac function of grade 3-4, etc.; 6. Having mental disease that requires medical therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity;AUC;odds ratio;;sensitivity;specificity;AUC;odds ratio; | — |
Countries
China
Contacts
Public ContactCongjian Xu;Congjian Xu ;
Obstetrics and Gynecology Hospital of Fudan University;Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed