Effectiveness of fecal DNA syndecan-2 methylation testing for detection of colorectal cancer in a high-risk Chinese population

doi:10.4251/wjgo.v16.i4.1361

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World Journal of Gastrointestinal Oncology

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Observational Study

World J Gastrointest Oncol. Apr 15, 2024; 16(4): 1361-1373
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1361

Table 1 Baseline data of subjects evaluated

Characteristics	Cases (N%)	mSDC2 (N%)		P value
Characteristics	Cases (N%)	(+) n = 87	(-) n = 948	P value
Gender				0.028^a
Male	502 (48.50)	52 (5.02)	450 (43.48)
Female	533 (51.50)	35 (3.38)	498 (48.12)
Age				< 0.001^b
40-49	373 (36.04)	15 (1.45)	358 (34.59)
50-59	406 (39.22)	39 (3.77)	367 (35.46)
60-69	211 (20.39)	25 (2.42)	186 (17.97)
70-79	45 (4.35)	8 (0.77)	37 (3.57)
Family history of CRC				< 0.001^b
Yes	99 (9.57)	18 (1.74)	81 (7.83)
No	936 (90.43)	69 (6.67)	867 (83.77)
History of colorectal polyps				0.406
Yes	252 (24.35)	18 (1.74)	234 (22.61)
No	783 (75.65)	69 (6.67)	714 (68.99)
History of chronic diarrhea				0.108
Yes	342 (33.04)	22 (2.13)	320 (30.92)
No	693 (66.96)	65 (6.28)	628 (60.68)
History of chronic constipation				0.747
Yes	493 (47.63)	40 (3.86)	453 (43.77)
No	542 (52.37)	47 (4.54)	495 (47.83)
History of hematochezia				0.692
Yes	580 (56.04)	47 (4.54)	533 (51.50)
No	455 (43.96)	40 (3.86)	415 (40.10)
History of appendicitis				0.243
Yes	66 (6.38)	3 (0.29)	63 (6.09)
No	969 (93.62)	84 (8.12)	885 (85.51)
History of cholecystitis				0.836
Yes	66 (6.38)	6 (0.58)	60 (5.80)
No	969 (93.62)	81 (7.83)	888 (85.80)
History of psychiatric trauma				0.890
Yes	63 (6.09)	5 (0.48)	58 (5.60)
No	972 (93.91)	82 (7.92)	890 (85.99)
Pathological classification				< 0.001^b
CRC	16 (1.55)	14 (1.35)	2 (0.19)
AA	65 (6.28)	26 (2.51)	39 (3.77)
NAA	189 (18.26)	8 (0.77)	181 (17.49)
Polyps	150 (14.49)	12 (1.16)	138 (13.33)
Others	615 (59.42)	27 (2.61)	588 (56.81)

^aP < 0.05.

^bP < 0.001.

mSDC: Syndecan-2 methylation; CRC: Colorectal cancer; AA: Advanced adenoma; NAA: Non-advanced adenoma; Polyps: Non-adenomatous polyps; Others: Totally normal colonoscopy, colitis and colonic diverticulum, etc.

Table 2 Primary outcomes of pathological findings on screening

Characteristics	Intestinal lesions (N%)				Others (N%)	P value
Characteristics	CRC	AA	NAA	Polyps	Others (N%)	P value
Gender						< 0.001^a
Male	9 (0.87)	43 (4.15)	109 (10.53)	77 (7.44)	264 (25.51)
Female	7 (0.68)	22 (2.13)	80 (7.73)	73 (7.05)	351 (33.91)
Age (yr)						< 0.001^a
40-49	3 (0.29)	8 (0.77)	48(4.64)	46 (4.44)	268 (25.89)
50-59	5 (0.48)	30 (2.90)	73 (7.05)	59 (5.70)	239 (23.09)
60-69	7 (0.68)	18 (1.74)	57 (5.51)	38 (3.67)	91 (8.79)
70-79	1 (0.10)	9 (0.87)	11 (1.06)	7 (0.68)	17 (1.64)
mSDC2						< 0.001^a
Positive	14 (1.35)	26 (2.51)	8 (0.77)	12 (1.16)	27 (2.61)
Negative	2 (0.19)	39 (3.77)	181 (17.49)	138 (13.33)	588 (56.81)

^aP < 0.001.

Table 3 Characteristics of colorectal cancer detected on screening

Characteristics	Colonoscopy (N = 16)	mSDC2 (N%)
Characteristics	Colonoscopy (N = 16)	Positive (n = 14)	Negative (n = 2)
Gender
Male	9 (56.25)	8 (50.00)	1 (6.25)
Female	7 (43.75)	6 (37.50)	1 (6.25)
Age (yr)
40-49	3 (18.75)	2 (12.50)	1 (6.25)
50-59	5 (31.25)	5 (31.25)	0 (0)
60-69	7 (43.75)	7 (43.75)	0 (0)
70-79	1 (6.25)	0 (0)	1 (6.25)
TNM stage
0/I/II	8 (50.00)	6 (43.7)	2 (12.50)
III/IV	5 (31.25)	5 (31.25)	0 (0)
Unknown	3 (18.75)	3 (18.75)	0 (0)
Tumor location
Proximal	3 (18.75)	3 (18.75)	0 (0)
Distal	13 (81.25)	11 (68.75)	2 (12.50)
Tumor size (mm)
≤ 30	9 (56.25)	7 (43.75)	2 (12.50)
> 30	7 (43.75)	7 (43.75)	0 (0)
Dysplasia
Low	0 (0)	0 (0)	0 (0)
Median	12 (75.00)	12 (75.00)	0 (0)
High	4 (25.00)	2 (12.50)	2 (12.50)

mSDC: Syndecan-2 methylation.

Table 4 Risk factors for detection of advanced colorectal neoplasia

Characteristics	B	SE	Wald	df	P value	OR	95%CI
Characteristics	B	SE	Wald	df	P value	OR	Lower limit	Upper limit
Gender
Male	-0.768	0.294	6.816	1	0.009^b	0.464	0.261	0.826
Age
40-49			22.792	3	< 0.001^c
50-59	-2.627	0.567	21.459	1	< 0.001^c	0.072	0.024	0.220
60-69	-1.612	0.499	10.422	1	0.001^c	0.200	0.075	0.531
70-79	-1.266	0.516	6.010	1	0.014^a	0.282	0.102	0.776
mSDC2
Positive	-2.798	0.320	76.308	1	< 0.001^c	0.061	0.033	0.114
Family history of CRC
Yes	-1.674	0.530	9.958	1	0.002^b	0.188	0.066	0.530
History of colorectal polyps
Yes	2.055	0.580	12.560	1	< 0.001^c	7.809	2.506	24.335
History of chronic diarrhea
Yes	0.077	0.405	0.036	1	0.850	1.080	0.488	2.388
History of chronic constipation
Yes	0.417	0.399	1.090	1	0.296	1.518	0.694	3.320
History of hematochezia
Yes	0.322	0.442	0.529	1	0.467	1.380	0.580	3.284
History of appendicitis
Yes	0.860	0.818	1.105	1	0.293	2.362	0.476	11.729
History of cholecystitis
Yes	-0.306	0.555	0.305	1	0.581	0.736	0.248	2.183
History of psychiatric trauma
Yes	1.287	0.912	1.991	1	0.158	3.621	0.606	21.633

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

CI: Confidence interval; B: Beta; SE: Standard error; df: Degree of freedom; OR: Odds ratio; CRC: Colorectal cancer; mSDC: Syndecan-2 methylation.

Table 5 Performance characteristics of the syndecan-2 methylation test regarding detection of colorectal neoplasia

Category	Colonoscopy (N = 1035)	mSDC2 test (N = 1035)		PPV % (95%CI)	NPV % (95%CI)
Category	Colonoscopy (N = 1035)	Positive (n = 87)	Sensitivity % (95%CI)	PPV % (95%CI)	NPV % (95%CI)
Colorectal cancer	16	14	87.50 (60.41-97.80)	16.09 (9.38-25.87)	99.79 (99.15-99.96)
Advanced adenoma	65	26	40.00 (28.28-52.90)	29.89 (20.78-40.79)	95.89 (94.37-97.02)
Advanced colorectal neoplasia	81	40	49.38 (38.19-60.64)	45.98 (35.36-56.96)	95.68 (94.13-96.84)
		Negative (n = 948)	Specificity % (95%CI)
Others	615	588	95.61 (93.59-97.03)
Others, polyps and NAA	954	907	95.07 (93.45-96.32)
Normal	552	527	95.47 (93.29-96.99)

mSDC: Syndecan-2 methylation; CI: Confidence interval; PPV: Positive predictive value; NPV: Negative predictive value; Others: Totally normal colonoscopy, colitis and colonic diverticulum, etc.; Polyps: Non-adenomatous polyps; NAA: Non-advanced adenoma; Normal: Totally normal colonoscopy.

Citation: Luo WF, Jiao YT, Lin XL, Zhao Y, Wang SB, Shen J, Deng J, Ye YF, Han ZP, Xie FM, He JH, Wan Y. Effectiveness of fecal DNA syndecan-2 methylation testing for detection of colorectal cancer in a high-risk Chinese population. World J Gastrointest Oncol 2024; 16(4): 1361-1373
URL: https://www.wjgnet.com/1948-5204/full/v16/i4/1361.htm
DOI: https://dx.doi.org/10.4251/wjgo.v16.i4.1361